Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months
| Group | Value (% change) | Spread |
|---|---|---|
| Exenatide BID | -5.28 | 3.23 |
| Placebo | -4.30 | 3.53 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: Enrollment was much slower than anticipated, leading to a decision to terminate the study early for enrollment futility.
Results were posted for this trial.
United States, Canada
1 trial · 1 stopped early · 1 with posted results
Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin
NCT00701935Aug 2008 to Jan 2012
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
A multicenter, randomized, double-blind, placebo-controlled trial will assess the effects of twice-daily subcutaneous injection with exenatide versus treatment with matching placebo injection on abdominal visceral fat content.
Placebo comparator
1
Experimental
2
Outcomes the sponsor listed as primary.
Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months
Time frame · baseline, 6 months
Percentage change in abdominal visceral fat
Percentage Change in Total Abdominal Fat From Baseline to 6 Months
Time frame · baseline, 6 months
Percentage change in total abdominal fat
Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months
Time frame · baseline, 6 months
Percentage change in subcutaneous abdominal fat
Change in HbA1c From Baseline to 6 Months
Time frame · baseline, 6 months
Change in HbA1c from baseline to 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.
Percentage of Patients With HbA1c <=7.0% at 6 Months
Time frame · 6 months
Percentage of patients with HbA1c values \<= 7.0% measured at 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.
Change in Fasting Plasma Glucose From Baseline to 6 Months
Time frame · baseline, 6 months
Change in Fasting plasma glucose
Change in Weight From Baseline to 6 Months
Time frame · baseline, 6 months
Change in weight
Change in Systolic Blood Pressure From Baseline to 6 Months
Time frame · baseline, 6 months
Change in Systolic blood pressure
Change in Diastolic Blood Pressure From Baseline to 6 Months
Time frame · baseline, 6 months
Change in Diastolic blood pressure
Change in Total Cholesterol From Baseline to 6 Months
Time frame · baseline, 6 months
Change in total cholesterol
Change in Triglycerides From Baseline to 6 Months
Time frame · baseline, 6 months
Change in triglycerides
Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months
Time frame · baseline, 6 months
Change in HDL cholesterol
Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event
Time frame · baseline, 6 months
All hypoglycemia episodes defined as major (results in loss of consciousness, seizure or coma resolving after administration of glucagon or glucose OR needing third-party assistance to resolve due to severe impairment in consciousness and associated with glucose concentration \< 2.8 mol/L.) or minor (non-major event with symptoms consistent with hypoglycemia and glucose value \< 2.8 mmol/L prior to treating) or symptoms of hypoglycemia (does not meet the criteria for a major or minor event).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (% change) | Spread |
|---|---|---|
| Exenatide BID | -5.28 | 3.23 |
| Placebo | -4.30 | 3.53 |
| Group | Value (% change) | Spread |
|---|---|---|
| Exenatide BID | -5.81 | 2.28 |
| Placebo | -3.74 | 2.36 |
| Group | Value (% change) | Spread |
|---|---|---|
| Exenatide BID | -7.27 | 1.93 |
| Placebo | -3.56 | 1.97 |
| Group | Value (% change) | Spread |
|---|---|---|
| Exenatide BID | -0.69 | 0.12 |
| Placebo | 0.19 | 0.15 |
| Group | Value (Percentage of patients) |
|---|---|
| Exenatide BID | 60.7 |
| Placebo | 21.4 |
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide BID | -1.47 | 0.36 |
| Placebo | -0.08 | 0.38 |
| Group | Value (kg) | Spread |
|---|---|---|
| Exenatide BID | -2.54 | 0.57 |
| Placebo | -0.33 | 0.72 |
| Group | Value (mmHg) | Spread |
|---|---|---|
| Exenatide BID | -7.48 | 12.57 |
| Placebo | 1.79 | 12.41 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide BIDSubcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for remainder of 6 months) | – | 3 / 43 | 38 / 43 |
| PlaceboSubcutaneous injection of placebo twice a day for 6 months | – | 1 / 37 | 25 / 37 |
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
Studies that cite this trial.
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Who could join, as posted.
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