Phase 3
Completed N=254
A Study to Evaluate the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly in Subjects With Type 2 Diabetes Mellitus (DURATION-5)
Source: ClinicalTrials.gov NCT00877890 ↗Enrolled (actual)
254
Serious AEs
3.2%
Results posted
Jun 2012
Primary outcomePrimary: Change in HbA1c From Baseline to Week 24 — -1.57; -0.90 percentage of total hemoglobin — p=<.0001
Summary
This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c From Baseline to Week 24 |
-1.57; -0.90 | <.0001 sig |
| SECONDARY Percentage of Subjects Achieving HbA1c Target of <7% |
58.1; 30.1 | <.0001 sig |
| SECONDARY Percentage of Subjects Achieving HbA1c Target of <=6.5% |
41.1; 16.3 | <.0001 sig |
| SECONDARY Change in Fasting Plasma Glucose From Baseline to Week 24 |
-25.1; -4.6 | 0.0006 sig |
| SECONDARY Percentage of Subjects Achieving Fasting Plasma Glucose Target of <=126 mg/dL |
50.4; 30.9 | 0.0008 sig |
| SECONDARY Change in Body Weight From Baseline to Week 24 |
-2.33; -1.37 | 0.0514 |
| SECONDARY Change in Sitting Systolic Blood Pressure From Baseline to Week 24 |
-2.9; -1.2 | 0.2367 |
| SECONDARY Change in Sitting Diastolic Blood Pressure From Baseline to Week 24 |
0.2; -0.1 | 0.7717 |
| SECONDARY Change in Total Cholesterol From Baseline to Week 24 |
-15.4; 0.6 | <.0001 sig |
| SECONDARY Change in High-density Lipoprotein (HDL) From Baseline to Week 24 |
0.0; 1.3 | 0.1251 |
| SECONDARY Ratio of Triglycerides at Week 24 to Baseline |
0.94; 0.99 | 0.2558 |
| SECONDARY Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events |
0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events |
0.75; 0.31; 0.00; 0.00 | — |
Eligibility Criteria
Inclusion Criteria
- Has been diagnosed with type 2 diabetes mellitus
- Has hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at screening
- Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening
- Has been treated with diet and exercise alone or in combination with a stable regimen of metformin (MET), a sulfonylurea (SU), a thiazolidinedione (TZD), a combination of metformin and an SU, a combination of metformin and a TZD, or a combination of an SU and a TZD for a minimum of 2 months prior to screening
- 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 screening:
- Hormone replacement therapy (female subjects)
- Oral contraceptives (female subjects)
- Antihypertensive agents
- Lipid-lowering agents
- Thyroid replacement therapy
- Antidepressant agents
- 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 ever been exposed to exenatide (exenatide once weekly [exenatide LAR], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) analog
- Has received any investigational drug within one month (or five half-lives of the investigational drug, whichever is greater) of screening
- Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following treatment excluded medications:
- Any dipeptidyl peptidase 4 (DPP-4) inhibitor within 3 months prior to screening
- Alpha glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of screening
- Insulin within 2 weeks of screening or for more than 1 week within 3 months of screening
- 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
Data sourced from ClinicalTrials.gov (NCT00877890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.