An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: exenatide; Drug: rosiglitazone

• Registration Number: NCT00135330
• Lead Sponsor: AstraZeneca

Brief Summary

This protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-08-24
• Study First Submitted QC: 2005-08-24
• Study First Posted: 2005-08-26
• Study Start: 2005-10
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2009-07-21
• Results First Submitted QC: 2009-07-21
• Results First Posted: 2009-08-28
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• HbA1c of 6.8% to 10.0%, inclusive.
• Body mass index (BMI) of 25 kg/m^2 to 40 kg/m^2, inclusive.

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Exclusion Criteria

• Have participated in this study previously, or have received exenatide, pramlintide acetate, GLP-1 analogs, or dipeptidyl peptidase-IV (DPP-IV) inhibitors

• Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start. This criterion includes drugs that have not received regulatory approval for any indication at the time of study start.

• Treated with any of the following medications:

  • Thiazolidinedione within 5 months of screening;
  • Sulfonylurea within 3 months of screening;
  • Metformin/sulfonylurea combination therapy within 3 months of screening;
  • Alpha-glucosidase inhibitor within 3 months of screening;
  • Meglitinide within 3 months of screening;
  • Insulin for more than 1 week within the 3 months prior to screening.
  • Symlin (pramlintide acetate) injection or Byetta (exenatide) injection at any time
  • Chronic (more than 2 weeks) or recent (within 4 weeks of study start) use of a drug that directly affects gastrointestinal motility
  • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start
  • Regular use of a medication with addictive potential such as an opiate, narcotic, or tranquilizer
  • Systemic antineoplastic agent
  • Systemic transplantation medication
  • Drugs for weight loss, including over-the-counter medications, within the 4 months prior to study start

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exenatide plus Rosiglitazone Arm	rosiglitazone	-
Exenatide Arm	exenatide	-
Exenatide plus Rosiglitazone Arm	exenatide	-
Rosiglitazone Arm	rosiglitazone	-

Primary Outcome Measures

Name	Time	Method
Change in ASIiAUC During a Hyperglycemic Clamp Test.	20 weeks	Change in insulin incremental area under the concentration-time curve (ASIiAUC) from baseline to week 20. ASIiAUC is a measure of beta-cell function.

Secondary Outcome Measures

Name	Time	Method
Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).	Week 20	Change in incremental for postprandial C-peptide (mmol/L) during MCT from baseline to week 20.
Hypoglycemia Rate Per 30 Days Per Patient	20 weeks	Average number of episodes of hypoglycemia per 30 days per patient
Pedal Edema Score	20 weeks	Pedal edema scores experienced by each patient throughout the study ("1+" indicates a patient experienced a pedal edema score of 1 , 2, or 3; "2+" indicates a patient experienced a pedal edema score of 2 or 3, etc.); Scale: 1. Slight pitting, no visible distortion, disappears rapidly; 2. A somewhat deeper pit than in 1+, but again no readily detectable distortion, and it disappears in 10 - 15 seconds; 3. The pit is noticeably deep and may last more than a minute; the dependent extremity looks fuller and swollen; 4. The pit is very deep, lasts as long as 2 - 5 minutes, and the dependent extremity is grossly distorted
Change in Fasting Total Cholesterol.	Week 20	Change in fasting total cholestrol from baseline to week 20.
Change in Fasting Triglycerides	Week 20	Ratio (endpint value divided by baseline value) of fasting triglycerides from baseline to week 20.
Change in Body Fat Mass During a Meal Challenge Test (MCT)	20 weeks	Change in body fat mass form baseline to week 20, as assessed during an MCT
Change in Waist Circumference	20 weeks	Change in waist circumference from baseline to week 20
Change in AUC for Glucose During a Meal Challenge Test (MCT).	Week 20	Change in AUC(15-180 min) for glucose during a MCT baseline to week 20.
Change in Insulin Sensitivity Index as Measured by M-value.	Week 20	Change of M-Value (mg/kg-min) during hyperinsulinemic euglycemic clamp test from baseline to week 20.
Change in Insulin AUC in the First Stage From Baseline to Endpoint.	Week 20	Change in insulin AUC in the first stage(uIU-min/ml) from baseline to week 20. "First stage" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test.
Change in Insulin iAUC From Baseline to Endpoint.	Week 20	Change in insulin iAUC in the first stage(uIU-min/ml) from baseline to week 20. "First stage" represents the first 10 minutes after reaching a steady state during a hyperglycemic clamp test.
Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).	Week 20	Ratio (value at endpoint divided by value at baseline) of AUC (15-180 min) for insulin (uIU-min/ml) during MCT.
Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).	Week 20	Change in incremental for postprandial insulin (mmol/L) during meal challenge test (MCT) from baseline to week 20.
Change in HbA1c	Week 20	Change in HbA1c from baseline to week 20.
Change in Fasting Proinsulin	Week 20	Ratio (endpoint value divided by baseline value) for fasting proinsulin, comparing endpoint (week 20) to baseline
Change in Body Weight	Week 20	Change in body weight from baseline to week 20.
Change in Percent Body Fat During a Meal Challenge Test (MCT)	20 weeks	Change in percent body fat from baseline to week 20, as assessed during an MCT
Change in Hip Circumference	20 weeks	Change in hip circumference form baseline to week 20
Change in Waist-to-hip Ratio	20 weeks	Change in waist-to-hip ratio (waist circumference divided by hip circumference) from baseline to week 20
Incidence of Hypoglycemia Events	20 weeks	Number of subjects experiencing hypoglycemia at any point during the study
Change in Fasting Serum Glucose Concentration.	Week 20	Change in fasting serum glucose concentration from baseline to week 20.
Change in Fasting C-peptide	Week 20	Change in fasting C-peptide from baseline to week 20.
Change in Fasting Insulin	Week 20	Change in fasting insulin from baseline to week 20.
Change in Fasting HDL Cholesterol	Week 20	Change in fasting high-density lipoprotein (HDL) cholesterol from baseline to week 20.
Change in Fasting LDL Cholesterol	Week 20	Change in fasting low-density lipoprotein (LDL) cholesterol from baseline to week 20.
Change in Lean Body Mass During a Meal Challenge Test (MCT)	20 weeks	Change in lean body mass from baseline to week 20, as assessed during an MCT
Change in AUC for C-peptide During a Meal Challenge Test (MCT).	Week 20	Ratio (value at endpoint divided by value at baseline) of AUC(15-180 min) for C-peptide (nmol-min/L) during a MCT from baseline to week 20.
Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).	Week 20	Change in incremental for postprandial glucose (mmol/L) during a MCT from baseline to week 20.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Spokane, Washington, United States