A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: exenatide and sitagliptin; Drug: exenatide and placebo

• Registration Number: NCT00870194
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-04-11
• Results First Submitted QC: 2011-05-19
• Results First Posted: 2011-06-17
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-20
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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• Have previously completed or withdrawn from this study or any other study investigating exenatide.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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	exenatide and sitagliptin	-
2	exenatide and placebo	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (Percent)	Baseline to 20 Weeks	Change in HbA1c from baseline to endpoint (Week 20); difference of base percent values \[X% - Y%\]

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Achieving HbA1c <=7.0%	Baseline to 20 Weeks	Percentage of patients whose baseline HbA1c was \> 7.0% achieving HbA1c \<=7.0% at endpoint (Week 20)
Percentage of Patients Achieving HbA1c <7.0%	Baseline to 20 Weeks	Percentage of patients whose baseline HbA1c was \>=7.0% achieving HbA1c \<7.0% at endpoint (Week 20)
Percentage of Patients Achieving HbA1c <=6.5%	Baseline to 20 Weeks	Percentage of patients whose baseline HbA1c was \> 6.5% achieving HbA1c \<=6.5% at endpoint (Week 20)
Change in FSG (mmol/L)	Baseline to 20 Weeks	Change in fasting serum glucose (FSG) from baseline to endpoint (Week 20)
Change in Body Weight (kg)	Baseline to 20 Weeks	Change in body weight from baseline to endpoint (Week 20)
Change in Waist Circumference (cm)	Baseline to 20 Weeks	Change in waist circumference from baseline to endpoint (Week 20)
Waist-to-Hip Ratio	Baseline to 20 Weeks	Change in waist-to-hip ratio from baseline to endpoint (Week20)
SMBG (mmol/L)	Baseline to 20 Weeks	7 point Self Monitored Blood Glucose Profiles - daily mean value (Week 20)
Change in Triglycerides (mmol/L)	Baseline to 20 Weeks	Change in triglycerides from baseline to endpoint (Week 20)
Change in HDL (mmol/L)	Baseline to 20 Weeks	Change in high-density lipoprotein (HDL) cholesterol from baseline to endpoint (Week 20)
Change in LDL (mmol/L)	Baseline to 20 Weeks	Change in low-density lipoprotein (LDL) cholesterol from baseline to endpoint (Week 20)
Change in Total Cholesterol (mmol/L)	Baseline to 20 Weeks	Change in total cholesterol from baseline to endpoint (Week 20)
Incidence of Hypoglycemia (Overall)	Baseline to 20 Weeks	Incidence of hypoglycemic episodes experienced overall during the study
Incidence of Severe Hypoglycemia(Overall)	Baseline to 20 Weeks	Incidence of severe hypoglycemia experienced overall during the study
Incidence of Nocturnal Hypoglycemia (Overall)	Baseline to 20 Weeks	Incidence of nocturnal hypoglycemia experienced overall during the study
Incidence of Confirmed Hypoglycemia(Overall)	Baseline to 20 Weeks	Incidence of confirmed hypoglycemia experienced overall during the study

Trial Locations

Locations (1)

Research Site; 🇲🇽 Tampico, Mexico