Phase 3 · Exenatide

NCT00603239 trial results

Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

Change in Glycosylated Hemoglobin (HbA1c) (Percentage), baseline and 26 weeks. Exenatide Twice Daily (BID): -0.84; Placebo: -0.10.

Participants
165
Status
completed
Completed
2009-07
Sponsor
AstraZeneca

As posted on ClinicalTrials.gov (NCT00603239), updated at source Apr 7, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00603239 measured first

Change in Glycosylated Hemoglobin (HbA1c)Percentage · baseline and 26 weeks · least squares mean
Exenatide Twice Daily (BID)n=110Placebon=54
-0.84(0.20)-0.10(0.23)
Side effects by arm

Side effects in NCT00603239

Percent of participants affected, Adverse events were collected from baseline to endpoint, regardless of relationship to study drug. Events were captured as actual terms and coded to MedDRA,version 12.0.. The most common events the registry lists.

EventExenatide Twice Daily (BID)Placebo
Any serious event0.9%0%
Nausea11.7%1.9%
Vomiting8.1%0%
Secondary outcomes

What else it measured

Percentage of Patients Achieving HbA1c <= 7%percentage of participants · 26 weeks · number
Exenatide Twice Daily (BID)n=104Placebon=52
49.036.5
Percentage of Patients Achieving HbA1c <= 6.5%percentage of participants · 26 weeks · number
Exenatide Twice Daily (BID)n=110Placebon=54
33.613.0
Change in Fasting Serum Glucose (FSG)mmol/L · baseline and 26 weeks · least squares mean
Exenatide Twice Daily (BID)n=103Placebon=53
-0.65(0.46)0.37(0.52)
Change in Body Weightkg · baseline and 26 weeks · least squares mean
Exenatide Twice Daily (BID)n=111Placebon=54
-1.43(0.61)-0.75(0.70)
Change in Waist Circumferencecm · baseline and 26 weeks · mean
Exenatide Twice Daily (BID)n=109Placebon=53
-2.26(3.83)-1.85(3.75)
Change in Beta-cell Functionratio · baseline and 26 weeks · geometric mean
Exenatide Twice Daily (BID)n=95Placebon=49
1.08(0.12)0.84(0.11)
Change in Insulin Sensitivity.ratio · baseline and 26 weeks · least squares mean
Exenatide Twice Daily (BID)n=95Placebon=49
1.09(0.11)1.07(0.13)
Number of Subjects Who Experienced an Episode of Minor HypoglycemiaParticipants · 26 weeks · number
Exenatide Twice Daily (BID)n=111Placebon=54
41
Change in Impact of Weight on Quality of Life (IWQOL)-Lite Scoreunits on a scale · baseline and 26 weeks · least squares mean
MeasureExenatide Twice Daily (BID)n=108Placebon=53
Change in Total Score-1.56(2.21)0.11(2.49)
Change in Physical Function component-3.84(3.06)-1.05(3.43)
Change in Self-Esteem component0.20(2.92)-0.54(3.28)
Change in Sexual Life component0.12(5.52)5.01(6.12)
Change in Public Distress component-0.48(2.61)-0.28(2.92)
Change in Work component-0.91(2.41)0.08(2.71)
Change in Euroqol - 5 Domain Quality of Life (EQ-5D) Scoreunits on a scale · baseline and 26 weeks · least squares mean
MeasureExenatide Twice Daily (BID)n=108Placebon=53
Change in Health State Score0.79(3.54)-2.94(3.97)
Change in Mobility component0.14(0.15)0.15(0.17)
Change in Self Care component0.08(0.14)0.03(0.16)
Change Usual Activities component0.17(0.15)0.19(0.17)
Change in Pain/Discomfort component0.29(0.16)0.23(0.18)
Change in Anxiety/Depression component-0.10(0.16)-0.26(0.18)
The trial

How NCT00603239 was run

This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.

  • Exenatide twice daily (BID)
  • Placebo
Who could join the trial

Inclusion Criteria: * Diagnosed with type 2 diabetes * If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days * The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day) * The metformin dose has been stable for at least 90 days * Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive. * Have a body mass index (BMI): 25 kg/m2 \< BMI \< 45 kg/m2. Exclusion Criteria: * Have participated in this study previously or any other study using exenatide (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously treated with exenatide or GLP-1 analogs * 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 screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry. * Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening * Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening. * Are currently treated with any of the following excluded medications: * Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening * Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening * Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening * Pramlintide acetate injection within 3 months prior to screening * Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics * 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

Published papers

Papers from NCT00603239

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.