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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

Overview

Status
Completed
Phase
Phase 3
Enrollment
551 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
13 countries

United States, Australia, Belgium, Brazil, Finland, Germany, Netherlands, Norway, Poland, Portugal, Puerto Rico, Spain, Sweden

Start
Jun 2003
Primary completion
Jul 2008
Completion
Jul 2008
First posted
11 May 2004 (estimated)
Last update posted
7 Apr 2015 (estimated)
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2003200420052006200720082009
  1. Ph 3

    Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

    NCT00082381

    Jun 2003 to Jul 2008

Registry summary

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

This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).

Interventions

  • Exenatide (AC2993)Drug
  • Insulin glargineDrug

Arms2

  • Experimental

    Exenatide Arm

    exenatide subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks

  • Active comparator

    Insulin Glargine Arm

    subcutaneous injection, once daily; forced titration to target blood glucose level

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Glycosylated Hemoglobin (HbA1c)

    Time frame · Baseline, week 26

    Registry description

    Change in HbA1c from baseline to week 26

Secondary outcomes(6)
  1. Percentage of Patients Achieving HbA1c <=7%

    Time frame · 26 weeks

    Registry description

    Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 26 (percentage = \[number of subjects with HbA1c \<=7% at week 26 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%).

  2. Change in Body Weight

    Time frame · Baseline, week 26

    Registry description

    Change in body weight from baseline to week 26

  3. Change in Fasting Serum Glucose

    Time frame · Baseline, week 26

    Registry description

    Change in fasting serum glucose from baseline to week 26

  4. Change in 7-point Self-monitored Blood Glucose (SMBG) Profile

    Time frame · Baseline, week 26

    Registry description

    Change in 7-point (pre-breakfast, 2 hour post breakfast, pre-lunch, 2 hour post lunch, pre-dinner, 2 hour post dinner, 0300 hours) SMBG profile from baseline to week 26

  5. Percentage of Patients With Hypoglycemic Events

    Time frame · 26 weeks

    Registry description

    Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study divided by the total number of patients who participated in the 26 week Parent Study

  6. Change in Rate of Hypoglycemic Events

    Time frame · Baseline, week 26

    Registry description

    Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26

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 26

Change in Glycosylated Hemoglobin (HbA1c)

GroupValue (percentage)Spread
Exenatide Arm8.130.07
Insulin Glargine Arm8.190.07
Secondary and other outcome results(6)
Secondary outcomeNumber· 26 weeks

Percentage of Patients Achieving HbA1c <=7%

GroupValue (percentage of participants)
Exenatide Arm46.43
Insulin Glargine Arm48.03
Secondary outcomeLeast squares mean· Baseline, week 26

Change in Body Weight

GroupValue (kg)Spread
Exenatide Arm88.421.16
Insulin Glargine Arm89.251.20
Secondary outcomeLeast squares mean· Baseline, week 26

Change in Fasting Serum Glucose

GroupValue (mmol/L)Spread
Exenatide Arm10.270.21
Insulin Glargine Arm10.460.21
Secondary outcomeLeast squares mean· Baseline, week 26

Change in 7-point Self-monitored Blood Glucose (SMBG) Profile

GroupValue (mmol/L)Spread
Exenatide Arm9.470.169
Insulin Glargine Arm9.500.173
Secondary outcomeNumber· 26 weeks

Percentage of Patients With Hypoglycemic Events

GroupValue (percentage of participants)
Exenatide Arm55.32
Insulin Glargine Arm59.93
Secondary outcomeLeast squares mean· Baseline, week 26

Change in Rate of Hypoglycemic Events

GroupValue (events per 30 days per patient)Spread
Exenatide Arm0.090.04
Insulin Glargine Arm0.110.04

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide ArmExenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)–8 / ?226 / ?
Insulin Glargine ArmInsulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)–10 / ?160 / ?

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

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

PubMed tag: none · 2012

15 results

Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment.

Fineman et al. 2012Diabetes, obesity & metabolismcited by 117

PMID 22236356DOI 10.1111/j.1463-1326.2012.01561.xPUB-22236356

Full text at the publisher15 results

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

Indexing hint: Randomized controlled trial · 2005

11 results

Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial.

Heine et al. 2005Annals of internal medicinecited by 548

PMID 16230722DOI 10.7326/0003-4819-143-8-200510180-00006PUB-16230722

Full text at the publisher11 results

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: * Patients have been treated with a stable dose of one of the following for at least 3 months prior to screening: 1. 1500 to 2550 mg/day immediate-release metformin (or 1500 to 2000 mg/day extended-release metformin) and at least an optimally effective dose of a sulfonylurea, or 2. a fixed-dose sulfonylurea/metformin combination therapy with the same sulfonylurea and metformin requirements as for the individual components. * HbA1c between 7.0% and 10.0%, inclusive. * History of stable body weight (not varying by \>10% for at least three months prior to screening). * Female patients are not breastfeeding, and female patients of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) Exclusion Criteria: * Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. * Patients are employed by Lilly or Amylin. * Patients have participated in this study previously or any other study using AC2993 or GLP-1 analogs. * Patients have participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry. * Patients have had greater than three episodes of severe hypoglycemia within 6 months prior to screening. * Patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer. * Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria. * Patients have a known allergy or hypersensitivity to insulin glargine, AC2993, or excipients contained in these agents. * Patients have characteristics contraindicating metformin or sulfonylurea use, according to product-specific label, in the opinion of the investigator. * Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine \>=1.5 mg/dL for males and \>=1.3 mg/dL for females. * Patients have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase/serum glutamicpyruvic transaminase greater than three times the upper limit of the reference range. * Patients have known hemoglobinopathy or chronic anemia. * Patients are receiving 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 screening. * Patients have used any prescription drug to promote weight loss within 3 months prior to screening. * Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes them from following and completing the protocol, in the opinion of the investigator. * Patients fail to satisfy the investigator of suitability to participate for any other reason.

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