Phase 4
Completed N=255
A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin
Source: ClinicalTrials.gov NCT00870194 ↗Enrolled (actual)
255
Serious AEs
3.9%
Results posted
Jun 2011
Primary outcomePrimary: Change in HbA1c (Percent) — -0.38; -0.68 Percent HbA1c — p=.012
Summary
The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c (Percent) |
-0.38; -0.68 | .012 sig |
| SECONDARY Percentage of Patients Achieving HbA1c <=7.0% |
29.5; 44.3 | .038 sig |
| SECONDARY Percentage of Patients Achieving HbA1c <7.0% |
26.6; 41.7 | .027 sig |
| SECONDARY Percentage of Patients Achieving HbA1c <=6.5% |
16.5; 20.7 | .480 |
| SECONDARY Change in FSG (mmol/L) |
0.06; -0.55 | .038 sig |
| SECONDARY Change in Body Weight (kg) |
-2.58; -2.20 | .266 |
| SECONDARY Change in Waist Circumference (cm) |
-3.25; -2.36 | .095 |
| SECONDARY Waist-to-Hip Ratio |
-0.01; -0.00 | .567 |
| SECONDARY SMBG (mmol/L) |
8.57; 8.16 | .207 |
| SECONDARY Change in Triglycerides (mmol/L) |
0.17; -0.07 | .055 |
| SECONDARY Change in HDL (mmol/L) |
-0.03; -0.01 | .269 |
| SECONDARY Change in LDL (mmol/L) |
0.06; 0.10 | .622 |
| SECONDARY Change in Total Cholesterol (mmol/L) |
0.09; 0.08 | .888 |
| SECONDARY Incidence of Hypoglycemia (Overall) |
5; 10 | .287 |
| SECONDARY Incidence of Severe Hypoglycemia(Overall) |
1; 0 | .498 |
| SECONDARY Incidence of Nocturnal Hypoglycemia (Overall) |
0; 3 | .247 |
| SECONDARY Incidence of Confirmed Hypoglycemia(Overall) |
1; 2 | 1.00 |
Eligibility Criteria
Inclusion Criteria
- Present with type 2 diabetes
- Patients have been treated with a stable dose of the following for at least 3 months prior to screening:
- 100 mg/day sitagliptin and
- ≥1500 mg/day metformin, or maximum tolerated dose (extended release or immediate-release).
- Have inadequate glycemic control as evidenced by an HbA1c between 7.1% and 9%, inclusive.
- Have a body mass index (BMI) ≥20 kg/m2 and <45 kg/m2
Exclusion Criteria
- Are currently enrolled in, or discontinued within the last 30 days (or longer, if local guidelines require) from, a clinical trial involving an off-label use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Have previously completed or withdrawn from this study or any other study investigating exenatide.
- Have a known allergy or hypersensitivity to exenatide, sitagliptin or excipients contained in exenatide or sitagliptin.
- Used drugs for weight loss (for example, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 1 month of screening.
- Are currently treated with any of the following excluded medications:
- Thiazolidinediones (TZD) within 3 months of screening.
- Sulfonylurea (SU) within 3 months of screening.
- Dipeptidyl peptidase-4 [DPP-4] inhibitors, with the exception of sitagliptin, within 3 months of screening.
- Meglitinide derivatives (for example, repaglinide or nateglinide) within 3 months of screening.
- Alpha-glucosidase inhibitors (for example, miglitol or acarbose) within 3 months of screening.
- Exogenous insulin within the 3 months prior to screening.
- Drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics.
- Systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous (IV), or intramuscular (IM) route used regularly (for longer than 1 month) or used within 1 month immediately prior to screening.
- Any other oral antidiabetic (OAD) agent, other than sitagliptin or metformin, within 3 months prior to screening.
Data sourced from ClinicalTrials.gov (NCT00870194). 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.