Primary outcomeLeast squares mean· baseline and 26 weeks
Change in Glycosylated Hemoglobin (HbA1c)
| Group | Value (Percentage) | Spread |
|---|---|---|
| Exenatide Twice Daily (BID) | -0.84 | 0.20 |
| Placebo | -0.10 | 0.23 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataSafety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin
NCTNCT00603239 (opens ClinicalTrials.gov in a new tab)Other idH8O-MC-GWCG
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 165 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Double masking
- Countries
5 countries
United States, Canada, Mexico, Romania, South Africa
- Start
- Jan 2008
- Primary completion
- Jul 2009
- Completion
- Jul 2009
- First posted
- 29 Jan 2008 (estimated)
- Last update posted
- 7 Apr 2015 (estimated)
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200820092010
- Ph 3
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin
NCT00603239Jan 2008 to Jul 2009
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- exenatideDrug
- placeboDrug
Arms2
Experimental
Exenatide twice daily (BID)
Placebo comparator
Placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Glycosylated Hemoglobin (HbA1c)
Time frame · baseline and 26 weeks
Registry description
Change in HbA1c from baseline to endpoint after 26 weeks of treatment (i.e., HbA1c at endpoint minus HbA1c at baseline)
Secondary outcomes(10)
Percentage of Patients Achieving HbA1c <= 7%
Time frame · 26 weeks
Registry description
Percentage of intent-to-treat (ITT) patients who had HbA1c \> 7% at baseline that decreased to \<= 7% at endpoint (Week 26 or early discontinuation)
Percentage of Patients Achieving HbA1c <= 6.5%
Time frame · 26 weeks
Registry description
Percentage of ITT patients who had achieved HbA1c \<= 6.5% at endpoint (Week 26 or early discontinuation)
Change in Fasting Serum Glucose (FSG)
Time frame · baseline and 26 weeks
Registry description
Change in FSG from baseline to endpoint (26 weeks)
Change in Body Weight
Time frame · baseline and 26 weeks
Registry description
Change in body weight from baseline to endpoint (26 weeks)
Change in Waist Circumference
Time frame · baseline and 26 weeks
Registry description
Change in waist circumference from baseline to endpoint (26 weeks)
Change in Beta-cell Function
Time frame · baseline and 26 weeks
Registry description
Change in homeostatic model assessment-beta cell (HOMA-B) from baseline to endpoint (Week 26) (outcome measure is presented as the ratio of endpoint HOMA-B divided by baseline HOMA-B). HOMA-B is a measure of pancreatic beta-cell function.
Change in Insulin Sensitivity.
Time frame · baseline and 26 weeks
Registry description
Change in homeostatic model assessment-insulin sensitivity (HOMA-S) from baseline to endpoint (26 weeks) (outcome measure is presented as the ratio of endpoint HOMA-S divided by baseline HOMA-S).
Number of Subjects Who Experienced an Episode of Minor Hypoglycemia
Time frame · 26 weeks
Registry description
Overall number of subjects who experienced an episode of minor hypoglycemia.
Change in Impact of Weight on Quality of Life (IWQOL)-Lite Score
Time frame · baseline and 26 weeks
Registry description
IWQOL-Lite analysis of change from baseline to endpoint (26 weeks). IWQOL-Lite is a 31-item questionnaire, assessing the domains of physical function, self-esteem, sexual life, public distress, and work. Response categories for each item range from 1 = "never true" to 5 = "always true."
Change in Euroqol - 5 Domain Quality of Life (EQ-5D) Score
Time frame · baseline and 26 weeks
Registry description
EQ-5D Score - change from baseline to endpoint (26 weeks). EQ-5D is a 5-item questionnaire used to characterize current health states. The tool and accompanying visual analog scale (VAS) assess 5 domains of quality of life, including mobility, self-care, usual activity, pain, and anxiety/depression. Weights are used to score the responses to the 5 domains, with 3 options possible in each domain: extreme problems, some/moderate problems, or no problems. Scores range from 0 to 1, with a score of 1 representing a perfect health state.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeNumber· 26 weeks
Percentage of Patients Achieving HbA1c <= 7%
| Group | Value (percentage of participants) |
|---|---|
| Exenatide Twice Daily (BID) | 49.0 |
| Placebo | 36.5 |
Secondary outcomeNumber· 26 weeks
Percentage of Patients Achieving HbA1c <= 6.5%
| Group | Value (percentage of participants) |
|---|---|
| Exenatide Twice Daily (BID) | 33.6 |
| Placebo | 13.0 |
Secondary outcomeLeast squares mean· baseline and 26 weeks
Change in Fasting Serum Glucose (FSG)
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Twice Daily (BID) | -0.65 | 0.46 |
| Placebo | 0.37 | 0.52 |
Secondary outcomeLeast squares mean· baseline and 26 weeks
Change in Body Weight
| Group | Value (kg) | Spread |
|---|---|---|
| Exenatide Twice Daily (BID) | -1.43 | 0.61 |
| Placebo | -0.75 | 0.70 |
Secondary outcomeMean· baseline and 26 weeks
Change in Waist Circumference
| Group | Value (cm) | Spread |
|---|---|---|
| Exenatide Twice Daily (BID) | -2.26 | 3.83 |
| Placebo | -1.85 | 3.75 |
Secondary outcomeGeometric mean· baseline and 26 weeks
Change in Beta-cell Function
| Group | Value (ratio) | Spread |
|---|---|---|
| Exenatide Twice Daily (BID) | 1.08 | 0.12 |
| Placebo | 0.84 | 0.11 |
Secondary outcomeLeast squares mean· baseline and 26 weeks
Change in Insulin Sensitivity.
| Group | Value (ratio) | Spread |
|---|---|---|
| Exenatide Twice Daily (BID) | 1.09 | 0.11 |
| Placebo | 1.07 | 0.13 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide Twice Daily (BID)Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks | – | 1 / 111 | 22 / 111 |
| PlaceboPlacebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks | – | 0 / 54 | 1 / 54 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
2 studies on this page
PubMed tag: none · 2012
11 results
Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index.
Pencek et al. 2012Postgraduate medicinecited by 45
PMID 22913891DOI 10.3810/pgm.2012.07.2567PUB-22913891
Full text at the publisher11 results
Indexing hint: Randomized controlled trial · 2010
7 results
A placebo-controlled trial of exenatide twice-daily added to thiazolidinediones alone or in combination with metformin.
Liutkus et al. 2010Diabetes, obesity & metabolismcited by 58
PMID 20977576DOI 10.1111/j.1463-1326.2010.01251.xPUB-20977576
Full text at the publisher7 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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