Type 2 DiabetesPhase 3NCT00661362

Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes

A Phase 3 study testing Saxagliptin and Metformin in people with Type 2 Diabetes, run by AstraZeneca at 30 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes
What is being tested?: Saxagliptin and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 570 participants
Where: 30 sitesin 3 countries
Study dates: Jun 2008to Sep 2009
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with Type 2 diabetes
Treatment with metformin at a stable dose >1500 mg/day
HbA1c ≥ 7.0% and ≤10.0%

Who cannot join

Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma

Trial locations and contacts

30 sites in 3 countries.

Country

City, postcode or hospital

30 sites in 3 countries

China16 sites

Research Site
Beijing, China
Research Site
Changchun, Jilin
Research Site
Changsha, Hunan
Research Site
Chengdu, Sichuan
Research Site
Chongqing, China
Research Site
Dalian, Liaoning
Research Site
Guangzhou, Guangdong
Research Site
Ha'er Bing, Hei Longjiang
Research Site
Hangzhou, Zhejiang
Research Site
Hefei, Anhui
Research Site
Nanjing, Jiangsu
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang, Liaoning
Research Site
Shijiazhuang, Hebei
Research Site
Tianjin
Research Site
Wuhan, Hubei

Other trials in China

South Korea9 sites

Research Site
Bucheon-si
Research Site
Daegu
Research Site
Goyang
Research Site
Gwangju
Research Site
Incheon
Research Site
Pusan
Research Site
Seongnam-si, Gyeonggi-do
Research Site
Seoul
Research Site
Uijeongbu-si

Other trials in South Korea

India5 sites

Research Site
Bangalore, Karnataka
Research Site
Bangalore
Research Site
Hyderabad, Andhra Pradesh
Research Site
Mangalore, Karnataka
Research Site
Nagpur, Maharashtra

Other trials in India

About this study

Official title: A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy

Conditions: Type 2 Diabetes
Being tested: Saxagliptin, Placebo, Metformin
Keywords: DPP-4 inhibitors, HbA1c, Incretins
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 Onglyza
Oral tablet, once daily for 24 weeks
PlaceboDrug
oral tablet, once daily for 24 weeks
MetforminDrug
Also called Glucophage
oral tablet, once daily for 24 weeks

Study groups in NCT00661362
Study group	Role	What they receive
1	Experimental	Metformin + Saxagliptin Receives: Drug: Saxagliptin; Drug: Metformin
2	Placebo comparator	Metformin + Placebo Receives: Drug: Placebo; Drug: Metformin

What is being measured

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

Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline HbA1c.
Measured: Baseline , Week 24

Secondary outcomes (5)

Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.
Measured: Baseline , Week 24
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL
Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline FPG.
Measured: Baseline , Week 24
Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup
Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.
Measured: Baseline , Week 24
Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup
Adjusted* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. *Adjusted for baseline PPG AUC.
Measured: Baseline , Week 24
Proportion of Patients Achieving a Therapeutic Glycemic Response
Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c < 7.0% for saxagliptin + metformin versus placebo + metformin at week 24
Measured: Baseline , Week 24

Timeline

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

Jun 2008Sep 2009

First posted18 Apr 2008 (estimated)
Study startJun 2008
Primary completionSep 2009
Study completionSep 2009

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 (2)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 570 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00661362
Sponsor's protocol ID: D1680C00006
Status last verified: Feb 2012
First submitted: 17 Apr 2008
Last updated: 8 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.
PubMed 27402391
Yang W, Pan CY, Tou C, Zhao J, Gause-Nilsson I. Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: a randomized controlled trial. Diabetes Res Clin Pract. 2011 Nov;94(2):217-24. doi: 10.1016/j.diabres.2011.07.035. Epub 2011 Aug 26.
PubMed 21871686

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?

See locations

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
Hypertension (Without Type 2 Diabetes Mellitus)
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 trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy
ClinicalTrials.gov ID: NCT00661362
Acronym / sponsor ID: D1680C00006
Conditions: Type 2 Diabetes
Keywords: DPP-4 inhibitors, HbA1c, Incretins
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 570 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Jun 2008
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 18 Apr 2008 (estimated)
Results: Posted 8 Mar 2012

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: 2

Arm	Type	Receives
1	Experimental	Drug: Saxagliptin, Drug: MetforminMetformin + Saxagliptin
2	Placebo comparator	Drug: Placebo, Drug: MetforminMetformin + Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosed with Type 2 diabetes
Treatment with metformin at a stable dose >1500 mg/day
HbA1c ≥ 7.0% and ≤10.0%

Key exclusion criteria (2 listed)

Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma

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: OnglyzaOral tablet, once daily for 24 weeks	Drug	1
Placebooral tablet, once daily for 24 weeks	Drug	2
MetforminAlso: Glucophageoral tablet, once daily for 24 weeks	Drug	1, 2

Primary outcome

Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
Time frame: Baseline , Week 24
Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. *Adjusted for baseline HbA1c.

5 secondary outcomes

Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L
Time frame: Baseline , Week 24
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL
Time frame: Baseline , Week 24
Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup
Time frame: Baseline , Week 24
Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup
Time frame: Baseline , Week 24
Proportion of Patients Achieving a Therapeutic Glycemic Response
Time frame: Baseline , Week 24

Results and safety

Results posted to the registry on 8 Mar 2012, 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 5 mg + Metformin	283	254
Placebo + Metformin	287	247

Primary outcome: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)

Time frame: Baseline , Week 24. Mean (Standard Error). Unit: percent

Measure	Saxagliptin 5 mg + Metformin n = 275	Placebo + Metformin n = 279
Baseline	7.90 (0.049)	7.94 (0.050)
Week 24	7.10 (0.056)	7.55 (0.062)
adjusted baseline HbA1c	-0.78 (0.051)	-0.37 (0.050)

Saxagliptin 5 mg + Metformin vs Placebo + Metformin: Mean Difference (Net): -0.42 (95% CI -0.55 to -0.29), p <0.0001, ANCOVA

Population analysed: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post baseline efficacy measurement.

5 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 5 mg + Metformin	8 of 283 (2.8%)	19 of 283 (6.7%)	Not reported
Placebo + Metformin	3 of 287 (1%)	13 of 287 (4.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27402391Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.
Derived from this study: PubMed 21871686Yang W, Pan CY, Tou C, Zhao J, Gause-Nilsson I. Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: a randomized controlled trial. Diabetes Res Clin Pract. 2011 Nov;94(2):217-24. doi: 10.1016/j.diabres.2011.07.035. Epub 2011 Aug 26.

Related trials for Type 2 Diabetes

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
Hypertension (Without Type 2 Diabetes Mellitus)
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)

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.

Peter Ohman, MD study director

AstraZeneca

Deborah Price, MSc study chair

AstraZeneca

30 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saxagliptin and Metformin in people with Type 2 Diabetes, run by AstraZeneca at 30 sites in 3 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 3 inclusion and 2 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 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China, South Korea, India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 8 Mar 2012). 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?

Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) (time frame: Baseline , Week 24). 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 NCT00661362, which also lists 2 linked publications.

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 8 Mar 2012.