Primary outcomeLeast squares mean· Day 1, Week 26
Change in HbA1c From Baseline to Week 26
| Group | Value (percentage of total hemoglobin) | Spread |
|---|---|---|
| Exenatide Once Weekly | -1.55 | 0.100 |
| Sitagliptin | -0.92 | 0.099 |
| Pioglitazone | -1.23 | 0.099 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)
NCTNCT00637273 (opens ClinicalTrials.gov in a new tab)Other idBCB106 (DURATION - 2)
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 514 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Double masking
- Countries
3 countries
United States, India, Mexico
- Start
- Jan 2008
- Primary completion
- Feb 2009
- Completion
- Jul 2009
- First posted
- 17 Mar 2008 (estimated)
- Last update posted
- 7 Apr 2015 (estimated)
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200820092010
- Ph 3
A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)
NCT00637273Jan 2008 to Jul 2009
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.
Interventions
- exenatide once weeklyDrug
- sitagliptinDrug
- pioglitazoneDrug
- placebo tabletDrug
- placebo once weeklyDrug
Arms3
Experimental
1
Active comparator
2
Active comparator
3
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in HbA1c From Baseline to Week 26
Time frame · Day 1, Week 26
Registry description
Absolute change in HbA1c from baseline (Day 1) to Week 26 \[Week 26 - Baseline\].
Secondary outcomes(11)
Percentage of Subjects Achieving HbA1c Target of <7% at Week 26
Time frame · Week 26
Registry description
Percentages of subjects achieving HbA1c target values of \<7% at Week 26.
Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26
Time frame · Week 26
Registry description
Percentages of subjects achieving HbA1c target values of \<=6.5% at Week 26.
Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26
Time frame · Week 26
Registry description
Percentages of subjects achieving HbA1c target values of \<=6.0% at Week 26.
Change in Body Weight From Baseline to Week 26
Time frame · Day 1, Week 26
Registry description
Change in body weight from baseline (Day 1) to Week 26.
Change in Fasting Plasma Glucose From Baseline to Week 26
Time frame · Day 1, Week 26
Registry description
Change in fasting plasma glucose from baseline (Day 1) to Week 26.
Change in Systolic Blood Pressure From Baseline to Week 26
Time frame · Day 1, Week 26
Registry description
Change in systolic blood pressure from baseline (Day 1) to Week 26.
Change in Diastolic Blood Pressure From Baseline to Week 26
Time frame · Day 1, Week 26
Registry description
Change in diastolic blood pressure from baseline (Day 1) to Week 26.
Change in Fasting Total Cholesterol From Baseline to Week 26
Time frame · Day 1, Week 26
Registry description
Change in fasting total cholesterol from baseline (Day 1) to Week 26.
Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26
Time frame · Day 1, Week 26
Registry description
Change in fasting HDL from baseline (Day 1) to Week 26.
Ratio of Fasting Triglycerides at Week 26 to Baseline
Time frame · Day 1, Week 26
Registry description
Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
Assessment on Event Rate of Treatment-emergent Hypoglycemic Events
Time frame · Day 1 to Week 26
Registry description
Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration \< 54 mg/dL prior to treatment. Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration \< 54 mg/dL prior to treatment and not classified as major hypoglycemia.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeNumber· Week 26
Percentage of Subjects Achieving HbA1c Target of <7% at Week 26
| Group | Value (percentage of subjects) |
|---|---|
| Exenatide Once Weekly | 58.8 |
| Sitagliptin | 30.7 |
| Pioglitazone | 43.6 |
Secondary outcomeNumber· Week 26
Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26
| Group | Value (percentage of subjects) |
|---|---|
| Exenatide Once Weekly | 38.8 |
| Sitagliptin | 15.7 |
| Pioglitazone | 26.7 |
Secondary outcomeNumber· Week 26
Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26
| Group | Value (percentage of subjects) |
|---|---|
| Exenatide Once Weekly | 13.8 |
| Sitagliptin | 9.0 |
| Pioglitazone | 4.8 |
Secondary outcomeLeast squares mean· Day 1, Week 26
Change in Body Weight From Baseline to Week 26
| Group | Value (kg) | Spread |
|---|---|---|
| Exenatide Once Weekly | -2.31 | 0.323 |
| Sitagliptin | -0.77 | 0.322 |
| Pioglitazone | 2.79 | 0.320 |
Secondary outcomeLeast squares mean· Day 1, Week 26
Change in Fasting Plasma Glucose From Baseline to Week 26
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Exenatide Once Weekly | -31.8 | 3.79 |
| Sitagliptin | -16.3 | 3.72 |
| Pioglitazone | -27.3 | 3.75 |
Secondary outcomeLeast squares mean· Day 1, Week 26
Change in Systolic Blood Pressure From Baseline to Week 26
| Group | Value (mmHg) | Spread |
|---|---|---|
| Exenatide Once Weekly | -3.6 | 0.97 |
| Sitagliptin | 0.2 | 0.95 |
| Pioglitazone | -1.6 | 0.95 |
Secondary outcomeLeast squares mean· Day 1, Week 26
Change in Diastolic Blood Pressure From Baseline to Week 26
| Group | Value (mmHg) | Spread |
|---|---|---|
| Exenatide Once Weekly | -1.4 | 0.57 |
| Sitagliptin | -0.4 | 0.57 |
| Pioglitazone | -2.5 | 0.56 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide Once WeeklyExenatide once weekly 2 mg subcutaneous weekly plus placebo oral once daily in the morning | – | 4 / 160 | 81 / 160 |
| SitagliptinSitagliptin 100 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly | – | 5 / 166 | 59 / 166 |
| PioglitazonePioglitazone 45 mg oral once daily in the morning plus placebo once weekly subcutaneous weekly | – | 10 / 165 | 61 / 165 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies7
Studies that cite this trial.
Studies with results
6 studies on this page
Indexing hint: Randomized controlled trial · 2013
12 results
Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals.
Meloni et al. 2013Cardiovascular diabetologycited by 12
PMID 23522121PMC3622579DOI 10.1186/1475-2840-12-48PUB-23522121
CC BY12 results
Indexing hint: Randomized controlled trial · 2013
16 results
Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials.
Grimm et al. 2013Postgraduate medicinecited by 52
PMID 23748506DOI 10.3810/pgm.2013.05.2660PUB-23748506
Full text at the publisher16 results
Indexing hint: Randomized controlled trial · 2013
8 results
Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data.
Malloy et al. 2013Postgraduate medicinecited by 6
PMID 23748507DOI 10.3810/pgm.2013.05.2661PUB-23748507
Full text at the publisher8 results
PubMed tag: none · 2012
15 results
Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment.
Fineman et al. 2012Diabetes, obesity & metabolismcited by 117
PMID 22236356DOI 10.1111/j.1463-1326.2012.01561.xPUB-22236356
Full text at the publisher15 results
Indexing hint: Randomized controlled trial · 2011
14 results
DURATION-2: efficacy and safety of switching from maximum daily sitagliptin or pioglitazone to once-weekly exenatide.
Wysham et al. 2011Diabetic medicine : a journal of the British Diabetic Associationcited by 91
PMID 21434995PMC3123706DOI 10.1111/j.1464-5491.2011.03301.xPUB-21434995
CC BY14 results
Indexing hint: Randomized controlled trial · 2010
7 results
Efficacy and safety of exenatide once weekly versus sitagliptin or pioglitazone as an adjunct to metformin for treatment of type 2 diabetes (DURATION-2): a randomised trial.
Bergenstal et al. 2010Lancet (London, England)cited by 457
PMID 20580422DOI 10.1016/s0140-6736(10)60590-9PUB-20580422
Full text at the publisher7 results
More studies
1 study on this page
PubMed tag: none · 2020
Corrected
Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.
Guja et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 6
PMID 32306296PMC7324446DOI 10.1007/s13300-020-00815-zPUB-32306296
Free to read · publisher termsCC BY-NC
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedPeyrot M, Bushnell DM, Best JH, Martin ML, Cameron A, Patrick DL. Development and validation of the self-management profile for type 2 diabetes (SMP-T2D). Health Qual Life Outcomes. 2012 Oct 5;10:125. doi: 10.1186/1477-7525-10-125. PMID 23039868
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Has been diagnosed with type 2 diabetes mellitus
* Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
* Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
* Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
* Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
1. Hormone replacement therapy (female subjects)
2. Oral contraceptives (female subjects)
3. Antihypertensive agents
4. Lipid-lowering agents
5. Thyroid replacement therapy
6. Antidepressant agents
7. Drugs known to affect body weight, including prescription medications (e.g. orlistat \[XENICAL®\], sibutramine \[MERIDIA®\], topiramate \[TOPAMAX®\]) and over-the-counter antiobesity agents
Exclusion Criteria:
* Has been previously exposed to exenatide once weekly
* Has donated blood within 60 days of study start or is planning to donate blood during the study
* Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
1. Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start
2. Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start
3. Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
4. Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
5. Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin
* Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
* Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use
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