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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

Overview

Status
Terminated
Phase
Phase 2
Enrollment
80 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Double masking
Countries
2 countries

United States, Canada

Start
Aug 2008
Primary completion
Jan 2012
Completion
Jan 2012
First posted
19 Jun 2008 (estimated)
Last update posted
10 Apr 2015 (estimated)
Conditions
Diabetes Mellitus

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010201120122013
  1. Ph 2

    Effect of Exenatide on Abdominal Fat Distribution in Patients With Type 2 Diabetes Pretreated With Metformin

    NCT00701935

    Aug 2008 to Jan 2012

    Terminated

Registry summary

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.

Interventions

  • placeboDrug
  • exenatideDrug

Arms2

  • Placebo comparator

    1

  • Experimental

    2

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months

    Time frame · baseline, 6 months

    Registry description

    Percentage change in abdominal visceral fat

Secondary outcomes(12)
  1. Percentage Change in Total Abdominal Fat From Baseline to 6 Months

    Time frame · baseline, 6 months

    Registry description

    Percentage change in total abdominal fat

  2. Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months

    Time frame · baseline, 6 months

    Registry description

    Percentage change in subcutaneous abdominal fat

  3. Change in HbA1c From Baseline to 6 Months

    Time frame · baseline, 6 months

    Registry description

    Change in HbA1c from baseline to 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.

  4. Percentage of Patients With HbA1c <=7.0% at 6 Months

    Time frame · 6 months

    Registry description

    Percentage of patients with HbA1c values \<= 7.0% measured at 6 months. HbA1c is a measurement of the amount of hemogobin that is glycosylated.

  5. Change in Fasting Plasma Glucose From Baseline to 6 Months

    Time frame · baseline, 6 months

    Registry description

    Change in Fasting plasma glucose

  6. Change in Weight From Baseline to 6 Months

    Time frame · baseline, 6 months

    Registry description

    Change in weight

  7. Change in Systolic Blood Pressure From Baseline to 6 Months

    Time frame · baseline, 6 months

    Registry description

    Change in Systolic blood pressure

  8. Change in Diastolic Blood Pressure From Baseline to 6 Months

    Time frame · baseline, 6 months

    Registry description

    Change in Diastolic blood pressure

  9. Change in Total Cholesterol From Baseline to 6 Months

    Time frame · baseline, 6 months

    Registry description

    Change in total cholesterol

  10. Change in Triglycerides From Baseline to 6 Months

    Time frame · baseline, 6 months

    Registry description

    Change in triglycerides

  11. Change in High-Density Lipoprotein (HDL) Cholesterol From Baseline to 6 Months

    Time frame · baseline, 6 months

    Registry description

    Change in HDL cholesterol

  12. Assessment of Event Rate of Treatment- Emergent Hypoglycemic Event

    Time frame · baseline, 6 months

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· baseline, 6 months

Percentage Change in Abdominal Visceral Fat From Baseline to 6 Months

GroupValue (% change)Spread
Exenatide BID-5.283.23
Placebo-4.303.53
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· baseline, 6 months

Percentage Change in Total Abdominal Fat From Baseline to 6 Months

GroupValue (% change)Spread
Exenatide BID-5.812.28
Placebo-3.742.36
Secondary outcomeLeast squares mean· baseline, 6 months

Percentage Change in Subcutaneous Abdominal Fat From Baseline to 6 Months

GroupValue (% change)Spread
Exenatide BID-7.271.93
Placebo-3.561.97
Secondary outcomeLeast squares mean· baseline, 6 months

Change in HbA1c From Baseline to 6 Months

GroupValue (% change)Spread
Exenatide BID-0.690.12
Placebo0.190.15
Secondary outcomeNumber· 6 months

Percentage of Patients With HbA1c <=7.0% at 6 Months

GroupValue (Percentage of patients)
Exenatide BID60.7
Placebo21.4
Secondary outcomeLeast squares mean· baseline, 6 months

Change in Fasting Plasma Glucose From Baseline to 6 Months

GroupValue (mmol/L)Spread
Exenatide BID-1.470.36
Placebo-0.080.38
Secondary outcomeLeast squares mean· baseline, 6 months

Change in Weight From Baseline to 6 Months

GroupValue (kg)Spread
Exenatide BID-2.540.57
Placebo-0.330.72
Secondary outcomeMean· baseline, 6 months

Change in Systolic Blood Pressure From Baseline to 6 Months

GroupValue (mmHg)Spread
Exenatide BID-7.4812.57
Placebo1.7912.41

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 / 4338 / 43
PlaceboSubcutaneous injection of placebo twice a day for 6 months–1 / 3725 / 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

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 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients between 18 and 85 years of age, inclusive. * Patients with type 2 diabetes * Patients have been treated with metformin, at a stable dose for at least 3 months prior to Visit 1 * Patients have HbA1c of 7.0% to 8.9%, inclusive. * Patients have a body mass index \>27 kg/m2 and \<40 kg/m2 and meet local CT scan body weight requirements. For South Asian, Japanese, and Chinese patients, a body mass index \>=25 kg/m2 is acceptable as the lower limit. * Patients have a history of stable body weight (not varying by \>2 kg in the 3 months prior to Visit 1). * Medications for the treatment of high blood pressure are stable with respect to treatment regimen for 4 weeks prior to Visit 1. * Stable regimen of lipid-lowering agents for 6 weeks prior to Visit 1. Exclusion Criteria: * Have received treatment in the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * 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 a history of renal transplantation, or are currently receiving renal dialysis. * Have had a clinically significant history of cardiac disease or presence of active cardiac disease within 1 year prior to Visit 1, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study. * Have known hemoglobinopathy or clinically significant, chronic anemia. * Known or are likely to become transfusion dependent during the study. * Have active, symptomatic proliferative retinopathy. * Are receiving chronic treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility. (i.e. metoclopramide, cisapride, and chronic use of macrolide antibiotics) * Have severe gastrointestinal disease, including gastroparesis. * Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 months immediately prior to Visit 1. * Have taken exenatide, liraglutide or any other GLP-1 receptor agonist in the past 6 months, either in a clinical study or as commercially available medication. Patients with known allergy to exenatide should be excluded. * Have used any prescription or over the counter drug to promote weight loss within 3 months prior to Visit 1, or intend to use such a drug during the study. (Examples: Xenical \[orlistat\], Meridia \[sibutramine\], Acutrim \[phenylpropanolamine\], Acomplia \[rimonabant\]). * Have participated in a structured weight loss program within 3 months prior to Visit 1, or intend to participate in such a plan during this study. * Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to Visit 1: Insulin; Thiazolidinediones; Alpha-glucosidase inhibitors; Sulfonylureas; Oral DPP-IV inhibitors; Meglitinides. * Are taking warfarin, or a coumarol derivative.

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