Diabetes Mellitus, Type 2Phase 2NCT01024244
A Study of LY2599506 in Patients With Type 2 Diabetes
A Phase 2 study testing LY2599506 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 16 sites in 5 countries.
Trial summary
The purpose of this study is to help answer the following questions: To test if taking LY2599506 for 12 weeks controls blood sugar better than taking placebo for 12 weeks. To evaluate the safety of LY2599506 in participants with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- LY2599506
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 16 sitesin 5 countries
- Study dates
- Dec 2009to Jul 2010
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have type 2 diabetes mellitus prior to entering the trial.
- Are currently being treated with diet and exercise therapy consistent with the local standards of medical care.
- May be treated with diet and exercise alone or in combination with a stable of metformin for at least 3 month before entering the trial.
- Have a hemoglobin A1c value between 7.0% and 10.0 %, inclusive.
- Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Male patients will be advised to use a reliable method of birth control during the study and until 3 months after the last dose of study medication if their partner is of child-bearing potential.
Who cannot join
- Use of insulin or any antidiabetic agent other than metformin during the 3 months prior entering the trial.
- Have a gastrointestinal disease that significantly impacts gastric emptying or motility (for example, severe gastroparesis or pyloric stenosis), in the opinion of the investigator, or have undergone gastric bypass or gastric banding surgery.
- Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness.
- Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
- Have cardiac autonomic neuropathy (for example, resting tachycardia or orthostatic hypotension), based on clinical signs, symptoms, or appropriate diagnostic testing.
- Have cardiac disease with functional status that is New York Heart Association Class II, III or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 month.
Show all 12Show fewer
- Have poorly controlled hypertension (that is, mean systolic blood pressure of greater or equal than 160 mm Hg or mean diastolic blood pressure of greater or equal than 100 mm Hg) history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization.
- Have fed or fasting state hypertriglyceridemia (defined as >6.8 millimoles per liter [mmol/L], 600 milligrams per deciliter [mg/dl]) at screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
- Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or repeated alanine transaminase (ALT) levels >2.5 times the upper limit of the reference range at screening.
- Have evidence of a significant active, uncontrolled endocrine or autoimmune abnormality, as judged by the Investigator at screening.
- Have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- Have a history of seizure disorder.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Russia4 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Arkhangelsk, 163045
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Moscow, 119435
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rostov-on-Don, 344022
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saint Petersburg, 194354
Spain4 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Alicante, 03114
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Alzira, 46600
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dos Hermanas, 41014
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Santa Cruz de Tenerife, 38320
United States3 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Syracuse, New York, 13210
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Toms River, New Jersey, 08753
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Topeka, Kansas, 66606
Australia3 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Box Hill, Victoria, 3128
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Daw Park, South Australia, 5041
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
St Leonards, New South Wales, 2065
Puerto Rico2 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Manati, 00674
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Juan, 00907
About this study
Official title: A 12-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY2599506 in Patients With Type 2 Diabetes Mellitus Treated With Diet and Exercise, With or Without Metformin
The purpose of this study is to help answer the following questions:
- To test if taking LY2599506 for 12 weeks controls blood sugar better than taking placebo for 12 weeks.
- To evaluate the safety of LY2599506 in participants with diabetes.
- To determine if LY2599506 has the ability to control blood sugar in participants with diabetes.
- To determine how much LY2599506 should be given to participants.
- To determine if LY2599506 has an effect on a participant's weight.
The study design consists of 4 study periods: a screening period, a 4-week dose adjustment period, an 8-week treatment period, and a 4-week follow-up period.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Placebo, LY2599506
- 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.
PlaceboDrug
Administered po BID, prior to morning and evening meals for 12 weeks.
LY2599506Drug
Also called Glucokinase Activator
Administered po for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 0 milligrams (mg) Placebo | Placebo comparator | Participants received 2 placebo capsules by mouth (po), twice daily (BID), prior to morning and evening meals for 12 weeks. Receives: Drug: Placebo |
| 100 mg LY2599506 | Experimental | Participants received 50-mg capsules of LY2599506 po BID (One 50 mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks. Receives: Drug: LY2599506 |
| 200 mg LY2599506 | Experimental | Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. Receives: Drug: LY2599506 |
| 400 mg LY2599506 | Experimental | Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. Receives: Drug: LY2599506 |
| 200 mg LY2599506 once daily | Experimental | Participants received 200-mg of LY2599506 po once daily (QD) (Two 100 mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks). Receives: Drug: LY2599506 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks
Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Measured: Baseline, 12 weeks
Secondary outcomes (20)
Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks
Measures the QT interval in the ECG. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Measured: Baseline, 12 weeks, 16 weeks
Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks
HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.
Measured: Baseline, 12 weeks, 16 weeks
Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks
HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S), as percentages of a normal reference population (normal young adults). The normal reference population was set at 100%. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not calculated or analyzed.
Measured: Baseline, 12 weeks, 16 weeks
Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks
Fasting lipids were measured after an overnight fast. Lipids measured included triglycerides, HDL-C, LDL-C, non-HDL-C, total cholesterol, and free fatty acids. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Measured: Baseline, 12 weeks, 16 weeks
Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks
Assesses 5 health domains: mobility, self-care, usual activity, pain, and anxiety/depression with 3 options each. Total scores range from 5 (no problem) to 15 (more severe or frequent problems). An algorithm maps the 5 domain outcomes to a single index (0-1). A higher score indicates better perceived health state. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Measured: Baseline, 12 weeks, 16 weeks
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks
Change in SBP and DBP following 12 weeks of therapy (Week 12 SBP minus SBP at baseline; Week 12 DBP minus DBP at baseline) and 16 weeks of therapy (Week 16 SBPB minus SBP at baseline; Week 16 DBP minus DBP at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Measured: Baseline, 12 weeks, 16 weeks
Number of Hypoglycemic Episodes During 12-Week Treatment Period and 4-week Follow-up Period
Hypoglycemia was defined as any time a participant feels s/he was experiencing a sign or symptom associated with hypoglycemia or had a blood glucose <70 mg/dL (3.9 mmol/L) even if it was not associated with signs or symptoms of hypoglycemia. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Measured: Baseline through 16 weeks
Change From Baseline in Body Weight at 12 Weeks and 16 Weeks
Weight was measured in the fasting state (with the exception of Visit 1) and after emptying the bladder. Participants were instructed to be lightly clothed and without shoes. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Measured: Baseline, 12 weeks, 16 weeks
Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks
SMBG levels were measured at the following 7 timepoints during the day: fasting pre-breakfast, 2 hours post-breakfast, prior to lunch, 2 hours post-lunch, prior to dinner, 2 hours postdinner, and prior to bed. Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Measured: Baseline, 4 weeks, 12 weeks, 16 weeks
Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period
Percentage of participants who required dose adjustments at the discretion of the investigator for participants with persistent blood glucose<70 milligrams per deciliter (mg/dL). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Measured: Baseline through 12 weeks
Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period
Lipase and amylase concentrations were assessed. Amylase normal limits for males and females are 28-100 units per liter (U/L) (18-50 years), 28-120 U/L (50-60 years), and 28-150 U/L (60-70 years). Normal lipase limits for males and females are 0-100 U/L (18-50 years; 50-60 years) and 0-120 U/L (60-70 years). Study GMAH was terminated after enrolling only 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Measured: Baseline through 12 weeks
Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period and 4-week Follow-up Period
Clinically significant elevations of ALT/SGPT were considered ≥3 times the upper limit of normal (ULN). The percentage of participants above 2- and 5-fold ULN was not analyzed due to the early termination of the trial. The percentage of participants with ALT 3-fold ULN or higher is presented.
Measured: Baseline through 12 weeks, Baseline through 16 weeks
Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks
DTSQ, an 8-item questionnaire, measures satisfaction with treatment, perceived frequency of hyperglycemia, and perceived frequency of hypoglycemia. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Measured: Baseline, 12 weeks, 16 weeks
Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks
Assesses 2 hypoglycemia domains, with each item score from 0 (never engages in behavior) to 4 (always engages in behavior): Behavioral (15 items; range 0-60) and Worry about hypoglycemia (18 items; range 0-72). Total score is the sum of both domains (range 0-132). Higher scores indicate greater negative impact. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall, and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading. As a result, this outcome measure was not analyzed.
Measured: Baseline, 12 weeks, 16 weeks
Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks
Comprise 6 subscales (34 items). Each item score: 1 (not troublesome) to 5 (extremely troublesome) and transformed to 0-4 scale. Subscale score=sum of item scale in each subscale/total number of items. Global score=sum of scores by dimension. All scores standardized (0-100). Higher scores=greater symptom burden. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Measured: Baseline, 12 weeks, 16 weeks
Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period
The average total daily dose (sum of assigned morning and afternoon doses), in milligrams (mg), at each visit. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Measured: Baseline through 12 weeks
Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506
The Cmax value measures the maximum plasma concentration at steady state following administration of doses of LY2599506. Due to the nature of the sparse sampling approach, Cmax was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Measured: Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12
Area Under the Concentration-time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506
The AUCtau values measure the area under the plasma concentration time curve at a dosing interval at steady state for LY2599506. Due to the nature of sparse sampling approach taken for the study AUC tau was estimated using the posthoc pharmacokinetic (PK) parameters obtained from population PK (PopPK) modeling. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure was not analyzed.
Measured: Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12
30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall
Hypoglycemia: any time a participant experienced a sign/symptom associated with hypoglycemia or had blood glucose <70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). The 30-day adjusted rate=(total number of episodes between 2 time intervals/number of days between intervals) X 30 days. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Measured: Baseline through 16 weeks
Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks
Heart rate was measured in heartbeats per minute. Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
Measured: Baseline, 12 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Terminated due to nonclinical safety findings
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.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024244
- Sponsor's protocol ID
- 12781
- Other IDs
- I2Q-MC-GMAH
- Status last verified
- Nov 2011
- First submitted
- 1 Dec 2009
- Last updated
- 2 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of LY2599506 in Patients With Type 2 Diabetes Mellitus Treated With Diet and Exercise, With or Without Metformin
- ClinicalTrials.gov ID
- NCT01024244
- Acronym / sponsor ID
- 12781
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to nonclinical safety findings
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 26 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to help answer the following questions:
- To test if taking LY2599506 for 12 weeks controls blood sugar better than taking placebo for 12 weeks.
- To evaluate the safety of LY2599506 in participants with diabetes.
- To determine if LY2599506 has the ability to control blood sugar in participants with diabetes.
- To determine how much LY2599506 should be given to participants.
- To determine if LY2599506 has an effect on a participant's weight.
The study design consists of 4 study periods: a screening period, a 4-week dose adjustment period, an 8-week treatment period, and a 4-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0 milligrams (mg) Placebo | Placebo comparator | Drug: PlaceboParticipants received 2 placebo capsules by mouth (po), twice daily (BID), prior to morning and evening meals for 12 weeks. |
| 100 mg LY2599506 | Experimental | Drug: LY2599506Participants received 50-mg capsules of LY2599506 po BID (One 50 mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks. |
| 200 mg LY2599506 | Experimental | Drug: LY2599506Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. |
| 400 mg LY2599506 | Experimental | Drug: LY2599506Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks. |
| 200 mg LY2599506 once daily | Experimental | Drug: LY2599506Participants received 200-mg of LY2599506 po once daily (QD) (Two 100 mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have type 2 diabetes mellitus prior to entering the trial.
- Are currently being treated with diet and exercise therapy consistent with the local standards of medical care.
- May be treated with diet and exercise alone or in combination with a stable of metformin for at least 3 month before entering the trial.
- Have a hemoglobin A1c value between 7.0% and 10.0 %, inclusive.
- Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Male patients will be advised to use a reliable method of birth control during the study and until 3 months after the last dose of study medication if their partner is of child-bearing potential.
Key exclusion criteria (12 listed)
- Use of insulin or any antidiabetic agent other than metformin during the 3 months prior entering the trial.
- Have a gastrointestinal disease that significantly impacts gastric emptying or motility (for example, severe gastroparesis or pyloric stenosis), in the opinion of the investigator, or have undergone gastric bypass or gastric banding surgery.
- Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness.
- Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.
- Have cardiac autonomic neuropathy (for example, resting tachycardia or orthostatic hypotension), based on clinical signs, symptoms, or appropriate diagnostic testing.
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 |
|---|---|---|
| PlaceboAdministered po BID, prior to morning and evening meals for 12 weeks. | Drug | 0 milligrams (mg) Placebo |
| LY2599506Also: Glucokinase ActivatorAdministered po for 12 weeks | Drug | 100 mg LY2599506, 200 mg LY2599506, 200 mg LY2599506 once daily, 400 mg LY2599506 |
Primary outcome
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks
Time frame: Baseline, 12 weeks
Change in HbA1c from baseline following 12 weeks of therapy (HbA1c at week 12 minus HbA1c at baseline). Study GMAH was terminated after enrolling 78 participants. Given the small sample size overall and per treatment arm, numerical summaries and statistical comparisons are not appropriate and may be scientifically/clinically misleading; therefore, this outcome measure is not presented.
20 secondary outcomes
Change From Baseline in the QT Interval in Electrocardiogram (ECG) at 12 Weeks and 16 Weeks
Time frame: Baseline, 12 weeks, 16 weeks
Change From Baseline in the Homeostasis Model Assessment (HOMA2) Pancreatic Beta Cell Function (%B) at 12 Weeks and 16 Weeks
Time frame: Baseline, 12 weeks, 16 weeks
Change From Baseline in the Homeostasis Model Assessment (HOMA2) of Insulin Sensitivity (%S) at 12 Weeks and 16 Weeks
Time frame: Baseline, 12 weeks, 16 weeks
Change From Baseline in Triglycerides, Low-density Lipoprotein Cholesterol (LDL-C), High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, Total Cholesterol, and Free Fatty Acids at 12 Weeks and 16 Weeks
Time frame: Baseline, 12 weeks, 16 weeks
Change From Baseline in the European Quality of Life -5 Dimension (EQ-5D) at 12 Weeks and 16 Weeks
Time frame: Baseline, 12 weeks, 16 weeks
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at 12 Weeks and 16 Weeks
Time frame: Baseline, 12 weeks, 16 weeks
Number of Hypoglycemic Episodes During 12-Week Treatment Period and 4-week Follow-up Period
Time frame: Baseline through 16 weeks
Change From Baseline in Body Weight at 12 Weeks and 16 Weeks
Time frame: Baseline, 12 weeks, 16 weeks
Change From Baseline in the Seven-Point Self-Monitored Blood Glucose (7-point SMBG) at 4 Weeks, 12 Weeks, and 16 Weeks
Time frame: Baseline, 4 weeks, 12 weeks, 16 weeks
Percentage of Participants Requiring Dose Adjustments During the 12-week Treatment Period
Time frame: Baseline through 12 weeks
Percentage of Participants With Lipase and Amylase Measurements Above 2-fold Upper Limits of Normal (ULN) During the 12-week Treatment Period
Time frame: Baseline through 12 weeks
Percentage of Participants With Clinically-Significant Elevations of Alanine Aminotransferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT) During the 12-week Treatment Period and 4-week Follow-up Period
Time frame: Baseline through 12 weeks, Baseline through 16 weeks
Change From Baseline in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 12 Weeks and 16 Weeks
Time frame: Baseline, 12 weeks, 16 weeks
Change From Baseline in the Adult Low Blood Sugar Survey (LBSS-33 Item Scale) at 12 Weeks and 16 Weeks
Time frame: Baseline, 12 weeks, 16 weeks
Changes From Baseline in the Diabetes Symptoms Checklist-Revised (DSC-R) at 12 Weeks and 16 Weeks
Time frame: Baseline, 12 weeks, 16 weeks
Mean Total Daily Dose of LY2599506 During the 12-week Treatment Period
Time frame: Baseline through 12 weeks
Maximum Plasma Concentration (Cmax) at the Steady State for LY2599506
Time frame: Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12
Area Under the Concentration-time Curve (AUC) at a Dosing Interval (AUCtau) at the Steady State for LY2599506
Time frame: Predose and 2 hours after dosing or predose and 4-12 hours after dosing in weeks 1, 2, 3, and 12
30-day Adjusted Rates of Self-reported Hypoglycemic Episodes Overall
Time frame: Baseline through 16 weeks
Change From Baseline in Heart Rate at 12 Weeks and 16 Weeks
Time frame: Baseline, 12 weeks, 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2599506 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 16 sites in 5 countries.
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 12 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: stopped early, as of the sponsor's last update on 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Russia, Spain, United States, Australia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
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 26 Oct 2011). 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?
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 12 Weeks (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2011.