Primary outcomeLeast squares mean· baseline and 8 Weeks
Change in Time-averaged Glucose During a 24 Hour Period
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Exenatide | -41.65 | 2.55 |
| Sitagliptin | -29.56 | 2.58 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataComparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
NCTNCT00729326 (opens ClinicalTrials.gov in a new tab)Other idH8O-US-GWCV
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 83 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Aug 2008
- Primary completion
- Oct 2009
- Completion
- Oct 2009
- First posted
- 7 Aug 2008 (estimated)
- Last update posted
- 9 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 4
Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione
NCT00729326Aug 2008 to Oct 2009
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione \[TZD\]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.
Interventions
- exenatideDrug
- sitagliptinDrug
- placeboDrug
- placeboDrug
Arms2
Experimental
Sequence A
Experimental
Sequence B
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Time-averaged Glucose During a 24 Hour Period
Time frame · baseline and 8 Weeks
Registry description
Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).
Secondary outcomes(18)
Change in Two-hour Postprandial Glucose After the Morning Meal
Time frame · baseline and 8 Weeks
Registry description
Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)
Change in Fasting Blood Glucose After the Morning Meal
Time frame · baseline and 8 Weeks
Registry description
Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint)
Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal
Time frame · baseline and 8 Weeks
Registry description
Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint)
Change in Postprandial Glucagon AUC Excursion After the Morning Meal
Time frame · baseline and 8 Weeks
Registry description
Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint)
Change in Postprandial Triglyceride AUC After the Morning Meal
Time frame · baseline and 8 Weeks
Registry description
Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint)
Change in Postprandial Triglyceride AUC Excursion After the Morning Meal
Time frame · baseline and 8 Weeks
Registry description
Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint)
Change in Postprandial C-peptide AUC After the Morning Meal
Time frame · baseline and 8 Weeks
Registry description
Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint)
Change in Postprandial C-peptide AUC Excursion After the Morning Meal
Time frame · baseline and 8 Weeks
Registry description
Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint)
Change in Postprandial Insulin AUC After the Morning Meal
Time frame · baseline and 8 Weeks
Registry description
Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint)
Change in Postprandial Insulin AUC Excursion After the Morning Meal
Time frame · baseline and 8 Weeks
Registry description
Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint)
Change in Postprandial Active GLP-1 AUC After the Morning Meal
Time frame · baseline and 8 Weeks
Registry description
Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint)
Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal
Time frame · baseline and 8 Weeks
Registry description
Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint)
Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)
Time frame · 4 Weeks
Registry description
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL
Episodes of Hypoglycemia (Baseline to Week 4)
Time frame · 4 weeks
Registry description
Number of episodes of hypoglycemia experienced during the first 4 weeks of the study
Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)
Time frame · 8 weeks
Registry description
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL
Episodes of Hypoglycemia (Week 4 to Week 8)
Time frame · 8 weeks
Registry description
Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study
Percentage of Patients Experiencing Hypoglycemia (Overall)
Time frame · 4 weeks and 8 weeks
Registry description
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL
Episodes of Hypoglycemia (Overall)
Time frame · 4 weeks and 8 weeks
Registry description
Number of episodes of hypoglycemia experienced overall during the study
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 outcomeLeast squares mean· baseline and 8 Weeks
Change in Two-hour Postprandial Glucose After the Morning Meal
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Exenatide | -108.35 | 4.36 |
| Sitagliptin | -44.43 | 4.40 |
Secondary outcomeLeast squares mean· baseline and 8 Weeks
Change in Fasting Blood Glucose After the Morning Meal
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Exenatide | -28.93 | 2.70 |
| Sitagliptin | -28.22 | 2.71 |
Secondary outcomeLeast squares mean· baseline and 8 Weeks
Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal
| Group | Value (pmol*hours/L) | Spread |
|---|---|---|
| Exenatide | -29.60 | 2.91 |
| Sitagliptin | -16.91 | 2.93 |
Secondary outcomeLeast squares mean· baseline and 8 Weeks
Change in Postprandial Glucagon AUC Excursion After the Morning Meal
| Group | Value (pmol*hours/L) | Spread |
|---|---|---|
| Exenatide | -30.94 | 2.12 |
| Sitagliptin | -14.93 | 2.13 |
Secondary outcomeLeast squares mean· baseline and 8 Weeks
Change in Postprandial Triglyceride AUC After the Morning Meal
| Group | Value (mg*hours/dL) | Spread |
|---|---|---|
| Exenatide | 0.83 | 0.03 |
| Sitagliptin | 0.87 | 0.03 |
Secondary outcomeLeast squares mean· baseline and 8 Weeks
Change in Postprandial Triglyceride AUC Excursion After the Morning Meal
| Group | Value (mg*hours/dL) | Spread |
|---|---|---|
| Exenatide | -108.16 | 8.38 |
| Sitagliptin | -41.39 | 8.45 |
Secondary outcomeLeast squares mean· baseline and 8 Weeks
Change in Postprandial C-peptide AUC After the Morning Meal
| Group | Value (nmol*hours/L) | Spread |
|---|---|---|
| Exenatide | -1.78 | 0.28 |
| Sitagliptin | 0.25 | 0.28 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ExenatideExenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. | – | 2 / 73 | 43 / 73 |
| SitagliptinExenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. | – | 0 / 73 | 37 / 73 |
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
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 70 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Have type 2 diabetes
* Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit 1.
* Have a fasting glucose concentration \<280 mg/dL at Visit 1
* Have been treated with a stable dose of immediate or extended release metformin for at least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least 120 days prior to screening.
* Are between 18 and 70 years of age, inclusive.
* Have body mass index ≥25 kg/m2 and ≤45 kg/m2.
* Have a history of stable body weight (not varying by \>10% for at least 3 months prior to screening).
* Can swallow oral study drug capsule, without splitting or crushing.
Exclusion Criteria:
* Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:
* Are breastfeeding.
* Test positive for pregnancy at the time of screening.
* Intend to become pregnant during the study.
* Have not practiced a reliable method of birth control (for example, use of oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for 3 months prior to screening.
* Treated with any of the following medications:
* Insulin, exenatide, pramlintide, sulfonylureas or meglitinides within 3 months of screening
* Alpha-glucosidase inhibitor within 2 months of screening.
* Drugs that directly affect gastrointestinal motility, including, but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.
* Use of a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phentermine, or similar over-the-counter medications) within 3 months prior to Visit 1.
* Systemic corticosteroids by oral, intravenous, or intramuscular route within 2 months of screening.
* Have a history of renal transplantation or are currently receiving renal dialysis.
* Have obvious clinical signs or symptoms of liver disease or acute or chronic hepatitis.
* Have known active proliferative retinopathy or macular edema expected to need treatment with focal photocoagulation within 3 months.
* Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
* Have had organ transplantation.
* Have received GLP-1 analogs other than exenatide or DPP-4 inhibitors within the previous 3 months.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
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