Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

• ClinicalTrials.gov Identifier: NCT00111540
• Recruitment Status: Completed
• First Posted: May 24, 2005
• Last Update Posted: February 23, 2015
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Study Description

Brief Summary:

This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Drug: exenatide	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 456 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus
• Study Start Date: November 2002
• Actual Primary Completion Date: September 2006
• Actual Study Completion Date: September 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: Exenatide; Exenatide 5 mcg for 4 weeks (transition) then 10 mcg to study termination	Drug: exenatide; subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination; Other Names: Byetta; exendin-4; AC2993

Outcome Measures

Primary Outcome Measures :

1. Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ]
   Change in HbA1c from Visit 1 to each visit up to open-ended study termination
2. Change in body weight from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ]
   Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination
3. Change in fasting plasma glucose from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ]
   Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination
4. Change in lipids from Visit 1 to each protocol visit [ Time Frame: Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target) ]
   Change in lipids from Visit 1 to each visit up to open-ended study termination

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• The subject has an HbA1c value <=11.0%
• The subject has a body mass index (BMI) of 25 kg/m^2 to 45 kg/m^2, inclusive

Exclusion Criteria:

• Is currently treated with certain medications, including exogenous insulin

Contacts and Locations

  Show 60 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

• Study Director: Lisa Porter, MD; Amylin Pharmaceuticals, LLC.

More Information

Publications of Results:

Blonde L, Klein EJ, Han J, Zhang B, Mac SM, Poon TH, Taylor KL, Trautmann ME, Kim DD, Kendall DM. Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes. Diabetes Obes Metab. 2006 Jul;8(4):436-47.

Buse JB, Klonoff DC, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Maggs DG, Wintle ME. Metabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials. Clin Ther. 2007 Jan;29(1):139-53.

Klonoff DC, Buse JB, Nielsen LL, Guan X, Bowlus CL, Holcombe JH, Wintle ME, Maggs DG. Exenatide effects on diabetes, obesity, cardiovascular risk factors and hepatic biomarkers in patients with type 2 diabetes treated for at least 3 years. Curr Med Res Opin. 2008 Jan;24(1):275-86.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.

Nelson P, Poon T, Guan X, Schnabel C, Wintle M, Fineman M. The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Diabetes Technol Ther. 2007 Aug;9(4):317-26.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00111540 History of Changes
• Other Study ID Numbers: 2993-119
• First Posted: May 24, 2005
• Last Update Posted: February 23, 2015
• Last Verified: January 2015

Keywords provided by AstraZeneca:

exenatide; diabetes; Amylin; exendin-4

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Exenatide; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Obesity Agents; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists