Type 2 Diabetes MellitusPhase 2NCT00950599

Study of Multiple Doses of Saxagliptin (BMS-477118)

A Phase 2 study testing Saxagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the positive efficacy trend among doses of saxagliptin (BMS-477118) in subjects with Type 2 diabetes mellitus by assessing the change from baseline in HbA1c following 12 weeks of double-blind treatment. Read more about this study

Who is it for?: Ages 21 to 70 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Saxagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 423 participants
Where: No sites listed yet
Study dates: May 2003to May 2004
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes who are drug-naive
Screening HbA1c ≥ 6.8% and ≤ 9.7%
Screening fasting or random C-peptide > 0.5 ng/mL
< 35 years old must be negative for anti-GAD antibodies
Body Mass Index < 35 kg/m2

Who cannot join

Symptoms of poorly controlled diabetes
History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening
Receipt of oral antihyperglycemic medications for more than six months in total since diagnosis
Significant cardiovascular history

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-477118 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Conditions: Type 2 Diabetes Mellitus
Being tested: Saxagliptin, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SaxagliptinDrug
Also called BMS-477118
Tablets, Oral, 2.5 mg, once daily, 12 weeks
SaxagliptinDrug
Also called BMS-477118
Tablets, Oral, 5 mg, once daily, 12 weeks
SaxagliptinDrug
Also called BMS-477118
Tablets, Oral, 10 mg, once daily, 12 weeks
SaxagliptinDrug
Also called BMS-477118
Tablets, Oral, 20 mg, once daily, 12 weeks
SaxagliptinDrug
Also called BMS-477118
Tablets, Oral, 40 mg, once daily, 12 weeks
SaxagliptinDrug
Also called BMS-477118
Tablets, Oral, 100 mg, once daily, 6 weeks
PlaceboDrug
Tablets, Oral, 0 mg, once daily, 6 and 12 weeks

Study groups in NCT00950599
Study group	Role	What they receive
Saxagliptin (2.5 mg)	Experimental	Not described Receives: Drug: Saxagliptin
Saxagliptin (5 mg)	Experimental	Not described Receives: Drug: Saxagliptin
Saxagliptin (10 mg)	Experimental	Not described Receives: Drug: Saxagliptin
Saxagliptin (20 mg)	Experimental	Not described Receives: Drug: Saxagliptin
Saxagliptin (40 mg)	Experimental	Not described Receives: Drug: Saxagliptin
Saxagliptin (100 mg)	Experimental	Not described Receives: Drug: Saxagliptin
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort
Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.
Measured: Baseline, Week 12
Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12

Secondary outcomes (82)

Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in fructosamine achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in fasting insulin achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in insulin achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in C-peptide achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a liquid meal tolerance test (MTT) achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts. Area Under the Curve (AUC) here is defined as the area under the plot of the serum concentration of glucose against time after ingesting the meal for the first 60 minutes after the subject drinks the liquid meal.
Measured: Baseline, Week 6
Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Measured: Baseline, Week 12
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Measured: Baseline, Week 6
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Measured: Baseline, Week 12
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Measured: Baseline, Week 6
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (postprandial) C-peptide 0-60 minute AUC response to a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort. Area Under the Curve (AUC) is defined as the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The AUC is of particular use in estimating bioavailability of drugs, and in estimating total clearance of drugs.
Measured: Baseline, Week 12
Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial glucose 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 15 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 30 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide 60 minutes after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucose excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 30-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 60-minute Postprandial Insulin Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) insulin excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 15-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (15 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort
Measured: Baseline, Week 12
Change From Baseline in 30-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 60-minute Postprandial C-peptide Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) C-peptide excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucagon at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucagon at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucagon 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 30-minute Postprandial Free Fatty Acids (FFA) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 30-minute Postprandial FFA at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) FFA 30 minutes after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucagon Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) glucagon excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts.
Measured: Baseline, Week 6
Change From Baseline in 30-minute Postprandial FFA Excursion at Week 12 in the 0-40 mg Cohort
Adjusted mean change from baseline in postprandial (after mealtime) FFA excursion (30 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort.
Measured: Baseline, Week 12
Change From Baseline in 15-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Measured: Baseline, Week 6
Change From Baseline in 15-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
Mean change from baseline in 15-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Measured: Baseline, Week 12
Change From Baseline in 30-minute Insulinogenic Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts.
Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Measured: Baseline, Week 6
Change From Baseline in 30-minute Insulinogenic Index at Week 12 in the 0-40 mg Cohort
Mean change from baseline in 30-minute insulinogenic index of a MTT achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The insulinogenic index is a unitless scale which is a measure of insulin production normalized for the glucose stimulus. Higher numbers mean more beta cell function (improvement). The low value is zero. The highest value obtainable is unknown.
Measured: Baseline, Week 12
Change From Baseline in Matsuda Index at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 6 in the 0-40 mg and the 0 \& 100 mg cohorts. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).
Measured: Baseline, Week 6
Change From Baseline in Matsuda Index at Week 12 in the 0-40 mg Cohort
Mean change from baseline in Matsuda index achieved at each dose of saxagliptin at Week 12 in the 0-40 mg cohort. The Matsuda index is a scale designed to give numbers between 0 and 12, with a linear relationship to other indices of insulin sensitivity. The higher the number, the better the insulin sensitivity (improvement).
Measured: Baseline, Week 12
Change From Baseline in A1C at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 \& 100 mg cohort.
Measured: Baseline, Week 14
Change From Baseline in A1C at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in A1C achieved at each dose of saxagliptin during the Follow-Up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 \& 100 mg cohort.
Measured: Baseline, Week 10, Week 16
Change From Baseline in FSG at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in FSG achieved at each dose of saxagliptin during Follow-Up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 \& 100 mg cohort.
Measured: Baseline, Week 8, Week 14
Change From Baseline in FSG at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in FSG achieved at each dose of saxagliptin during the follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 \& 100 mg cohort.
Measured: Baseline, Week 10, Week 16
Change From Baseline in Fructosamine at 2 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 14 in the 0-40 mg cohort and at Week 8 in the 0 \& 100 mg cohort.
Measured: Baseline, Week 8, Week 14
Change From Baseline in Fructosamine at 4 Weeks After Discontinuation of Double-Blind Study Medication in the 0-40 and 0 & 100 mg Cohorts
Mean change from baseline in fructosamine achieved at each dose of saxagliptin during the Follow-up period at Week 16 in the 0-40 mg cohort and at Week 10 in the 0 \& 100 mg cohort.
Measured: Baseline, Week 10, Week 16
Change From Baseline in A1C at Week 6 by Baseline A1C Category in the 0 & 100 Cohort
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin at Week 6 in subjects with baseline A1C <7%, ≥7% to <8%, ≥8% to <9%, and ≥9% in the 0 \& 100 mg cohort.
Measured: Baseline, Week 6
Change From Baseline in FSG at Week 6 in Subjects by Baseline FSG Category in the 0 & 100 mg Cohort.
Adjusted mean change from baseline in FSG achieved at each dose of saxagliptin at Week 6 in subjects with baseline FSG <140 mg/dL, ≥140 mg/dL to <180 mg/dL, and ≥ 180 mg/dL in the 0 \& 100 mg cohort.
Measured: Baseline, Week 6
Change From Baseline in 60 Minute Postprandial Glucose at Week 6 by Baseline Category in the 0 & 100 mg Cohort
Adjusted mean change from baseline in 60-minute postprandial glucose achieved at each dose of saxagliptin at Week 6 in subjects with baseline 60-minute postprandial glucose <140 mg/dL, ≥140 to <200 mg/dL, and ≥200 mg/dL in the 0 \& 100 mg cohort.
Measured: Baseline, Week 6
Percentage of Participants Achieving A1C < 7% at Week 6 in the 0 & 100 mg Cohort
Percentage of participants achieving A1C < 7%, the American Diabetic Association's defined goal for glycemia, at each dose of saxagliptin at Week 6 in the 0 \& 100 mg cohort.
Measured: Week 6
Change From Baseline in 60-minute Postprandial FFA Excursion at Week 6 in the 0 & 100 mg Cohort
Adjusted mean change from baseline in postprandial FFA excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 \& 100 mg cohort. (Note: this analysis was not performed.)
Measured: Baseline, Week 6
Change From Baseline in 60-minute Postprandial Glucagon Excursion at Week 6 in the 0 & 100 mg Cohort
Adjusted mean change from baseline in postprandial glucagon excursion (60 minutes minus 0 minutes) after a MTT achieved at each dose of saxagliptin at Week 6 in the 0 \& 100 mg cohort. (Note: this analysis was not performed.)
Measured: Baseline, Week 6
Discontinuations During the Double-Blind Phase Due to Lack of Glycemic Control
Number of participants discontinuing from the double-blind phase due to lack of glycemic control at Week 4 and Week 6. (Note: this analysis was not performed.)
Measured: Week 4, Week 6
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0-40 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Measured: up to Week 12 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Double-Blind Treatment Period in the 0 & 100 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Measured: up to Week 6 for AEs; up to 30 days post-double-blind period but prior to follow-up period if any for SAEs and up to 30 days post-double-blind period for Discontinuations
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0-40 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Measured: From Week 12 to Week 16 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Discontinuations During the Follow-up Period in the 0 & 100 mg Cohort
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Measured: From Week 6 to Week 10 for AEs; up to 30 days post follow-up in both cohorts for SAEs and Discontinuations

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2003May 2004

First posted3 Aug 2009 (estimated)
Study startMay 2003
Primary completionMay 2004
Study completionMay 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 423 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00950599
Sponsor's protocol ID: CV181-008
Status last verified: Mar 2015
First submitted: 31 Jul 2009
Last updated: 3 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Rosenstock J, Sankoh S, List JF. Glucose-lowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naive patients with type 2 diabetes. Diabetes Obes Metab. 2008 May;10(5):376-86. doi: 10.1111/j.1463-1326.2008.00876.x. Epub 2008 Mar 18.
PubMed 18355324

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Evaluate the Safety and Efficacy of BMS-477118 as Monotherapy in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT00950599
Acronym / sponsor ID: CV181-008
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 423 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2003
Primary completion: May 2004 (actual)
Study completion: May 2004 (actual)
First posted: 3 Aug 2009 (estimated)
Results: Posted 23 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Saxagliptin (2.5 mg)	Experimental	Drug: Saxagliptin
Saxagliptin (5 mg)	Experimental	Drug: Saxagliptin
Saxagliptin (10 mg)	Experimental	Drug: Saxagliptin
Saxagliptin (20 mg)	Experimental	Drug: Saxagliptin
Saxagliptin (40 mg)	Experimental	Drug: Saxagliptin
Saxagliptin (100 mg)	Experimental	Drug: Saxagliptin
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Type 2 diabetes who are drug-naive
Screening HbA1c ≥ 6.8% and ≤ 9.7%
Screening fasting or random C-peptide > 0.5 ng/mL
< 35 years old must be negative for anti-GAD antibodies
Body Mass Index < 35 kg/m2

Key exclusion criteria (4 listed)

Symptoms of poorly controlled diabetes
History of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening
Receipt of oral antihyperglycemic medications for more than six months in total since diagnosis
Significant cardiovascular history

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SaxagliptinAlso: BMS-477118Tablets, Oral, 2.5 mg, once daily, 12 weeks	Drug	Saxagliptin (2.5 mg)
SaxagliptinAlso: BMS-477118Tablets, Oral, 5 mg, once daily, 12 weeks	Drug	Saxagliptin (5 mg)
SaxagliptinAlso: BMS-477118Tablets, Oral, 10 mg, once daily, 12 weeks	Drug	Saxagliptin (10 mg)
SaxagliptinAlso: BMS-477118Tablets, Oral, 20 mg, once daily, 12 weeks	Drug	Saxagliptin (20 mg)
SaxagliptinAlso: BMS-477118Tablets, Oral, 40 mg, once daily, 12 weeks	Drug	Saxagliptin (40 mg)
SaxagliptinAlso: BMS-477118Tablets, Oral, 100 mg, once daily, 6 weeks	Drug	Saxagliptin (100 mg)
PlaceboTablets, Oral, 0 mg, once daily, 6 and 12 weeks	Drug	Placebo

Primary outcome

Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Positive efficacy trend among doses of saxagliptin by assessing the adjusted mean change from baseline in A1C in the 0-40 mg cohort. The unit of measurement for A1C is percent.
Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Adjusted mean change from baseline in A1C achieved at each dose of saxagliptin versus placebo at Week 12 in the 0-40 mg cohort.

82 secondary outcomes

Change From Baseline in A1C at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in Fasting Serum Glucose (FSG) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in FSG at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in Fructosamine at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in Fructosamine at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in Insulin at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in C-peptide at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in Postprandial Glucose 0-60 Minute Area Under the Curve (AUC) at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in Postprandial Glucose 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in Postprandial Insulin 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in Postprandial C-peptide 0-60 Minute AUC at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in 15-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in 60-minute Postprandial Glucose at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in 15-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in 60-minute Postprandial Glucose at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in 15-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in 30-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in 60-minute Postprandial Insulin at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in 15-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in 30-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in 60-minute Postprandial Insulin at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in 15-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in 30-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in 60-minute Postprandial C-peptide at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in 15-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in 30-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in 60-minute Postprandial C-peptide at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6
Change From Baseline in 15-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in 30-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in 60-minute Postprandial Glucose Excursion at Week 12 in the 0-40 mg Cohort
Time frame: Baseline, Week 12
Change From Baseline in 15-minute Postprandial Insulin Excursion at Week 6 in the 0-40 and 0 & 100 mg Cohorts
Time frame: Baseline, Week 6

Results and safety

Results posted to the registry on 23 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saxagliptin 2.5 mg (0-40 mg Cohort)	55	48
Saxagliptin 5 mg (0-40 mg Cohort)	47	37
Saxagliptin 10 mg (0-40 mg Cohort)	63	54
Saxagliptin 20 mg (0-40 mg Cohort)	54	43
Saxagliptin 40 mg (0-40 mg Cohort)	52	45
Placebo (0-40 mg Cohort)	67	55
Saxagliptin 100 mg (0 & 100 mg Cohort)	44	44
Placebo (0 & 100 mg Cohort)	41	35
Saxa 0-40 mg Cohort (Follow-up Period)	0	0
Saxa 0 & 100 mg Cohort (Follow-up Period)	0	0

Primary outcome: Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: percentage of glycosylated hemoglobins

Measure	Saxagliptin 2.5 mg (0-40 mg Cohort) n = 51	Saxagliptin 5 mg (0-40 mg Cohort) n = 42	Saxagliptin 10 mg (0-40 mg Cohort) n = 60	Saxagliptin 20 mg (0-40 mg Cohort) n = 51	Saxagliptin 40 mg (0-40 mg Cohort) n = 50	Placebo (0-40 mg Cohort) n = 62
Value	-0.67 (0.80)	-0.95 (0.97)	-0.81 (0.91)	-0.74 (0.93)	-0.78 (1.04)	-0.29 (0.82)

Saxagliptin 2.5 mg (0-40 mg Cohort) vs Saxagliptin 5 mg (0-40 mg Cohort) vs Saxagliptin 10 mg (0-40 mg Cohort) vs Saxagliptin 20 mg (0-40 mg Cohort) vs Saxagliptin 40 mg (0-40 mg Cohort) vs Placebo (0-40 mg Cohort): p = 0.9888, Kruskal-Wallis

Population analysed: Randomized participants. To be included in analysis of positive efficacy trend in change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

Primary outcome: Change From Baseline in A1C at Week 12 in the 0-40 mg Cohort

Time frame: Baseline, Week 12. Mean (Standard Error). Unit: percentage of glycosylated hemoglobins

Measure	Saxagliptin 2.5 mg (0-40 mg Cohort) n = 51	Saxagliptin 5 mg (0-40 mg Cohort) n = 42	Saxagliptin 10 mg (0-40 mg Cohort) n = 60	Saxagliptin 20 mg (0-40 mg Cohort) n = 51	Saxagliptin 40 mg (0-40 mg Cohort) n = 50	Placebo (0-40 mg Cohort) n = 62
Value	-0.72 (0.12)	-0.90 (0.14)	-0.81 (0.11)	-0.74 (0.12)	-0.80 (0.12)	-0.27 (0.11)

Saxagliptin 2.5 mg (0-40 mg Cohort) vs Saxagliptin 5 mg (0-40 mg Cohort) vs Saxagliptin 10 mg (0-40 mg Cohort) vs Saxagliptin 20 mg (0-40 mg Cohort) vs Saxagliptin 40 mg (0-40 mg Cohort) vs Placebo (0-40 mg Cohort): p = 0.9888, ANCOVA

Population analysed: Randomized participants. To be included in analysis of change from baseline to Week 12 Last Observation Carried Forward (LOCF), participants must have had a baseline and at least 1 post-baseline measurement.

82 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Saxagliptin 10 mg (0-40 mg Cohort)	1 of 63 (1.6%)	36 of 63 (57.1%)	Not reported
Saxagliptin 100 mg (0 & 100 mg Cohort)	0 of 44 (0%)	16 of 44 (36.4%)	Not reported
Saxagliptin 2.5 mg (0-40 mg Cohort)	1 of 55 (1.8%)	35 of 55 (63.6%)	Not reported
Saxagliptin 20 mg (0-40 mg Cohort)	2 of 54 (3.7%)	33 of 54 (61.1%)	Not reported
Saxagliptin 40 mg (0-40 mg Cohort)	0 of 52 (0%)	27 of 52 (51.9%)	Not reported
Saxagliptin 5 mg (0-40 mg Cohort)	0 of 47 (0%)	23 of 47 (48.9%)	Not reported
Placebo (0 & 100 mg Cohort)	0 of 41 (0%)	17 of 41 (41.5%)	Not reported
Placebo (0-40 mg Cohort)	2 of 67 (3%)	38 of 67 (56.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18355324Rosenstock J, Sankoh S, List JF. Glucose-lowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naive patients with type 2 diabetes. Diabetes Obes Metab. 2008 May;10(5):376-86. doi: 10.1111/j.1463-1326.2008.00876.x. Epub 2008 Mar 18.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Saxagliptin in people with Type 2 Diabetes Mellitus, run by AstraZeneca.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analysis of Test for Positive Efficacy Trend in Change From Baseline in Hemoglobin A1c (A1C) at Week 12 in the 0-40 mg Cohort (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00950599, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.