Trial · Interventional

CompletedPhase 3Results postedRegistry data

Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

NCTNCT00097500Other id2993-114

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 69 participants (actual)
Sponsor: AstraZeneca · Industry
Design: Randomized · Open label (no masking)
Countries: 3 countries
Finland, Netherlands, Sweden
Start: Sept 2004
Primary completion: Dec 2009
Completion: Dec 2009
First posted: 25 Nov 2004 (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

2004200520062007200820092010

Ph 3
Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes
NCT00097500
Sept 2004 to Dec 2009

Registry summary

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

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

Interventions

exenatideDrug
Insulin glargineDrug
MetforminDrug

Arms2

Experimental
Exenatide Arm
Exenatide and Metformin
Active comparator
Insulin Glargine Arm
Insulin Glargine and Metformin

Primary outcomes1

Outcomes the sponsor listed as primary.

Beta-cell Function After 52 Weeks of Therapy
Time frame · Baseline (week -2) and 52 weeks
Registry description
Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \[i.e., clamp time 290 min to 300 min\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline \[week -2\]).

Secondary outcomes(8)

Beta-cell Function 4 Weeks After Cessation of Therapy
Time frame · Baseline (week -2) and 56 weeks
Registry description
Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period \[i.e., clamp time 290 min to 300 min\]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline \[week -2\]).
Change in First Phase C-peptide Release
Time frame · baseline (week -2), 52 weeks, and 56 weeks
Registry description
Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline \[week -2\]). C-peptide is measured as a surrogate marker of insulin secretion. First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure.
Change in Second Phase C-peptide Release
Time frame · baseline (-2 weeks), 52 weeks, and 56 weeks
Registry description
Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline \[week -2\]). C-peptide is measured as a surrogate marker of insulin secretion. Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure.
Change in Glycosylated Hemoglobin (HbA1c)
Time frame · Week 0 and week 52
Registry description
Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0).
Change in Fasting Plasma Glucose
Time frame · 0 weeks and 52 weeks
Registry description
Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0).
Seven Point Self Monitored Blood Glucose (SMBG) Measurements
Time frame · 0 weeks and 52 weeks
Registry description
SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime).
Change in Body Weight
Time frame · 0 weeks and 52 weeks
Registry description
Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0).
M-value at Baseline, Week 52 and Week 56
Time frame · baseline (week -2), 52 weeks, and 56 weeks
Registry description
M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period). Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp.

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 (week -2) and 52 weeks

Beta-cell Function After 52 Weeks of Therapy

Group	Value (ratio)	Spread
Exenatide Arm	2.89	0.27
Insulin Glargine Arm	1.15	0.11

Secondary and other outcome results(7)

Secondary outcomeLeast squares mean· Baseline (week -2) and 56 weeks

Beta-cell Function 4 Weeks After Cessation of Therapy

Group	Value (ratio)	Spread
Exenatide Arm	1.02	0.06
Insulin Glargine Arm	1.08	0.07

Secondary outcomeLeast squares mean· baseline (week -2), 52 weeks, and 56 weeks

Change in First Phase C-peptide Release

Group	Value (ratio)	Spread
Exenatide Arm	1.72	0.11
Insulin Glargine Arm	1.13	0.07

Secondary outcomeLeast squares mean· baseline (-2 weeks), 52 weeks, and 56 weeks

Change in Second Phase C-peptide Release

Group	Value (ratio)	Spread
Exenatide Arm	2.88	0.18
Insulin Glargine Arm	1.01	0.07

Secondary outcomeLeast squares mean· Week 0 and week 52

Change in Glycosylated Hemoglobin (HbA1c)

Group	Value (percent)	Spread
Exenatide Arm	-0.97	0.14
Insulin Glargine Arm	-0.87	0.15

Secondary outcomeLeast squares mean· 0 weeks and 52 weeks

Change in Fasting Plasma Glucose

Group	Value (mmol/L)	Spread
Exenatide Arm	-1.53	0.25
Insulin Glargine Arm	-3.10	0.27

Secondary outcomeMean· 0 weeks and 52 weeks

Seven Point Self Monitored Blood Glucose (SMBG) Measurements

Group	Value (mmol/L)	Spread
Exenatide Arm	8.92	1.80
Insulin Glargine Arm	8.38	1.91

Secondary outcomeLeast squares mean· 0 weeks and 52 weeks

Change in Body Weight

Group	Value (kg)	Spread
Exenatide Arm	-3.80	0.87
Insulin Glargine Arm	0.75	0.95

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Exenatide Arm5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.	–	3 / 36	32 / 36
Insulin Glargine ArmDosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.	–	1 / 33	31 / 33

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

Studies5

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Meta-analysis (pooled) · 2025

15 results

Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.

Natale et al. 2025The Cochrane database of systematic reviewscited by 8

PMID 39963952PMC11834151DOI 10.1002/14651858.cd015849.pub2PUB-39963952

Rights unknown15 results

Source link See results (15)

Indexing hint: Randomized controlled trial · 2019

10 results

Exenatide twice-daily does not affect renal function or albuminuria compared to titrated insulin glargine in patients with type 2 diabetes mellitus: A post-hoc analysis of a 52-week randomised trial.

Muskiet et al. 2019Diabetes research and clinical practicecited by 17

PMID 31078666DOI 10.1016/j.diabres.2019.05.001PUB-31078666

Rights unknown10 results

Source link See results (10)

Indexing hint: Randomized controlled trial · 2011

4 results

Effects of exenatide on measures of β-cell function after 3 years in metformin-treated patients with type 2 diabetes.

Bunck et al. 2011Diabetes carecited by 204

PMID 21868779PMC3161303DOI 10.2337/dc11-0291PUB-21868779

Free to read · publisher termsCC BY-NC-ND4 results

Read at source See results (4)

Indexing hint: Randomized controlled trial · 2010

7 results

One-year treatment with exenatide vs. insulin glargine: effects on postprandial glycemia, lipid profiles, and oxidative stress.

Bunck et al. 2010Atherosclerosiscited by 114

PMID 20494360DOI 10.1016/j.atherosclerosis.2010.04.024PUB-20494360

Full text at the publisher7 results

Publisher page See results (7)

Indexing hint: Randomized controlled trial · 2009

6 results

One-year treatment with exenatide improves beta-cell function, compared with insulin glargine, in metformin-treated type 2 diabetic patients: a randomized, controlled trial.

Bunck et al. 2009Diabetes carecited by 302

PMID 19196887PMC2671094DOI 10.2337/dc08-1797PUB-19196887

Free to read · publisher termsCC BY-NC-ND6 results

Read at source See results (6)

Eligibility

Who could join, as posted.

Sex: All
Age: from 30 Years up to 75 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Diagnosis of type 2 diabetes, but otherwise healthy * HbA1c between 6.6% and 9.5%, inclusive. * Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive. * Treated with a stable dose of metformin for at least 2 months prior to screening. Exclusion Criteria: * Patients previously in a study using exenatide. * Treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening). * Treated with insulin within 3 months of screening.

PepBank is a research reference. Talk to a doctor before you use any peptide.