Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients

NCTNCT00360334Other idH8O-BP-GWBG

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 235 participants (actual)
Sponsor: AstraZeneca · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United Kingdom
Start: Jun 2006
Primary completion: Apr 2008
Completion: Apr 2008
First posted: 4 Aug 2006 (estimated)
Last update posted: 7 Apr 2015 (estimated)
Conditions: Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2006200720082009

Ph 3
A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
NCT00360334
Jun 2006 to Apr 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a phase 3 trial designed to compare the effects of twice daily exenatide plus oral antidiabetic agents (OADs) and once-daily insulin glargine plus OADs with respect to glycemic control, as measured by hemoglobin A1c, with minimum weight gain, in patients with uncontrolled type 2 diabetes on OADs.

Interventions

exenatideDrug
insulin glargineDrug

Arms2

Experimental
1
Active comparator
2

Primary outcomes1

Outcomes the sponsor listed as primary.

Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)
Time frame · 26 weeks
Registry description
Composite endpoint evaluating effect of treatment on glycemic control and weight

Secondary outcomes(20)

Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg
Time frame · 26 weeks
Registry description
Composite endpoint evaluating effect of treatment on glycemic control and weight
Change in Fasting Serum Glucose
Time frame · 26 weeks
Registry description
Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)
Percent of Patients Achieving HbA1c ≤ 7.4%
Time frame · 26 weeks
Registry description
Percent of patients achieving specified HbA1c target at endpoint
Percent of Patients Achieving HbA1c < 7%
Time frame · 26 weeks
Registry description
Percent of patients achieving specified HbA1c target at endpoint
Percent of Patients Achieving HbA1c < 6.5%
Time frame · 26 weeks
Registry description
Percent of patients achieving specified HbA1c target at endpoint
Change in 7 Point Self Monitored Blood Glucose Profile
Time frame · 26 weeks
Registry description
Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day
Change in Body Mass Index (BMI)
Time frame · 26 weeks
Registry description
Change in BMI from baseline to endpoint
Change in Waist Circumference
Time frame · 26 Weeks
Registry description
Change in waist circumference from baseline to endpoint
Change in Waist-to-hip Ratio
Time frame · 26 weeks
Registry description
Change in waist-to-hip ratio from baseline to endpoint
Change in Body Weight
Time frame · 26 weeks
Registry description
Change in body weight from baseline to endpoint
Percent Change in Body Weight
Time frame · 26 Weeks
Registry description
Percent change in baseline body weight at endpoint
Percent of Patients Achieving 5% Weight Loss
Time frame · 26 weeks
Registry description
Percent of patients who lost at least 5% of baseline body weight at endpoint
Percent of Patients Achieving 10% Weight Loss
Time frame · 26 weeks
Registry description
Percent of patients who lost at least 10% of baseline body weight at endpoint
Change in Systolic Blood Pressure
Time frame · 26 weeks
Registry description
Change in systolic blood pressure from baseline to endpoint
Change in Diastolic Blood Pressure
Time frame · 26 weeks
Registry description
Change in diastolic blood pressure from baseline to endpoint
Change in Fasting Serum Total Cholesterol (TC)
Time frame · 26 weeks
Registry description
Change in TC from baseline to endpoint
Change in High Density Lipoprotein (HDL) Cholesterol
Time frame · 26 weeks
Registry description
Change in HDL cholesterol from baseline to endpoint
Change in TC to HDL Cholesterol Ratio
Time frame · 26 weeks
Registry description
Change in TC to HDL cholesterol ratio from baseline to endpoint
Change in Fasting Serum Triglycerides
Time frame · 26 weeks
Registry description
Change in fasting serum triglycerides from baseline to endpoint
Change in Low Density Lipoprotein (LDL) Cholesterol
Time frame · 26 weeks
Registry description
Change in LDL cholesterol from baseline to endpoint

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 outcomeNumber· 26 weeks

Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)

Group	Value (percentage of participants)
Exenatide	53.4
Insulin Glargine	19.8

Secondary and other outcome results(7)

Secondary outcomeNumber· 26 weeks

Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg

Group	Value (Percentage of participants)
Exenatide	52.5
Insulin Glargine	16.4

Secondary outcomeLeast squares mean· 26 weeks

Change in Fasting Serum Glucose

Group	Value (mmol/L)	Spread
Exenatide	-2.12	0.25
Insulin Glargine	-3.61	0.25

Secondary outcomeNumber· 26 weeks

Percent of Patients Achieving HbA1c ≤ 7.4%

Group	Value (Percentage of participants)
Exenatide	54.2
Insulin Glargine	61.2

Secondary outcomeNumber· 26 weeks

Percent of Patients Achieving HbA1c < 7%

Group	Value (Percentage of participants)
Exenatide	34.7
Insulin Glargine	43.1

Secondary outcomeNumber· 26 weeks

Percent of Patients Achieving HbA1c < 6.5%

Group	Value (Percentage of participants)
Exenatide	15.3
Insulin Glargine	11.2

Secondary outcomeMean· 26 weeks

Change in 7 Point Self Monitored Blood Glucose Profile

Group	Value (mmol/L)	Spread
Exenatide	9.98	2.11
Insulin Glargine	9.88	2.07

Secondary outcomeLeast squares mean· 26 weeks

Change in Body Mass Index (BMI)

Group	Value (kg/m^2)	Spread
Exenatide	34.49	0.49
Insulin Glargine	33.71	0.49

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Exenatide5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks	–	5 / ?	105 / ?
Insulin Glarginedosing based on treat to target protocol	–	5 / ?	94 / ?

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

Publisher page See results (11)

Indexing hint: Randomized controlled trial · 2009

7 results

Exenatide compared with long-acting insulin to achieve glycaemic control with minimal weight gain in patients with type 2 diabetes: results of the Helping Evaluate Exenatide in patients with diabetes compared with Long-Acting insulin (HEELA) study.

Davies et al. 2009Diabetes, obesity & metabolismcited by 117

PMID 19930005PMC2810445DOI 10.1111/j.1463-1326.2009.01154.xPUB-19930005

CC BY7 results

Download PDF See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 30 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Diagnosed with type 2 diabetes * Currently being treated with the following: Dual or triple oral therapy - on a stable combination and dose for at least 3 months. * HbA1c between 7.5% and 10.0%. * BMI \>27. Exclusion Criteria: * Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to study. * Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which a medical or surgical treatment was given) within 30 days prior to entry into the study. * Treatment with the following medications: \*Insulin as outpatient therapy within last 3 months; \*Meglitinides, or acarbose within the last 3 months; \*Regular use of any drugs that directly affect gastrointestinal motility; \*Any previous (study) therapy with exenatide or glucagon-like peptide-1 (GLP-1) analogue; \*Anti-obesity agent use within the last 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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