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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

NCTNCT00434954 (opens ClinicalTrials.gov in a new tab)Other idH8O-SB-GWBN
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
494 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Germany

Start
Feb 2007
Primary completion
Jun 2009
Completion
Jun 2009
First posted
14 Feb 2007 (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
2007200820092010
  1. Ph 3

    Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

    NCT00434954

    Feb 2007 to Jun 2009

Registry summary

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

This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.

Interventions

  • exenatide twice daily (BID)Drug
  • premixed insulin aspart twice daily (BID)Drug

Arms2

  • Experimental

    Exenatide Twice Daily (BID)

  • Active comparator

    Premixed Insulin Aspart Twice Daily (BID)

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in Glycosylated Hemoglobin (HbA1c)

    Time frame · Baseline and 26 weeks

    Registry description

    Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)

  2. Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)

    Time frame · 26 weeks

    Registry description

    Risk for first hypoglycemic episode (blood glucose \<=3.9 mmol/L or severe episode) to occur up to week 26

Secondary outcomes(10)

  1. Percentage of Subjects Achieving HbA1c Target of < 6.5%

    Time frame · 26 weeks

    Registry description

    Percentage of subjects achieving HbA1c target of \< 6.5% at the end of study (week 26) \[i.e., number of subjects who achieved HbA1c \< 6.5% divided by total number of subjects times 100%\].

  2. Percentage of Subjects Achieving HbA1c Target of < 7.0%

    Time frame · 26 weeks

    Registry description

    Percentage of subjects achieving HbA1c target of \< 7.0% at the end of study (week 26) \[i.e., number of subjects who achieved HbA1c \< 7.0% divided by total number of subjects times 100%\].

  3. Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)

    Time frame · 26 weeks

    Registry description

    Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)\[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%\]

  4. Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)

    Time frame · 26 weeks

    Registry description

    Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) \[i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%\].

  5. 7 Point Self-monitored Blood Glucose (SMBG) Profiles

    Time frame · Baseline and 26 weeks

    Registry description

    7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am).

  6. Blood Lipid Levels

    Time frame · Baseline and 26 weeks

    Registry description

    Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26)

  7. Change in Body Weight

    Time frame · Baseline and 26 weeks

    Registry description

    Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0)

  8. Change in Body Mass Index (BMI)

    Time frame · Baseline and 26 weeks

    Registry description

    Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0)

  9. Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)

    Time frame · Baseline and 26 weeks

    Registry description

    Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction.

  10. Patient Reported Outcomes: Quality of Life (SF-12)

    Time frame · Baseline and 26 weeks

    Registry description

    SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores \> 50 indicate an above-average health status.

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 and 26 weeks

Change in Glycosylated Hemoglobin (HbA1c)

GroupValue (Percentage of glycosylated hemoglobin)Spread
Exenatide Twice Daily-1.000.05
Premixed Insulin Aspart Twice Daily-1.140.05
Primary outcomeNumber· 26 weeks

Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)

GroupValue (Percentage of participants)
Exenatide Twice Daily8.0
Premixed Insulin Aspart Twice Daily20.5
Secondary and other outcome results(6)
Secondary outcomeNumber· 26 weeks

Percentage of Subjects Achieving HbA1c Target of < 6.5%

GroupValue (Percentage of participants)
Exenatide Twice Daily27.6
Premixed Insulin Aspart Twice Daily24.9
Secondary outcomeNumber· 26 weeks

Percentage of Subjects Achieving HbA1c Target of < 7.0%

GroupValue (Percentage of participants)
Exenatide Twice Daily49.2
Premixed Insulin Aspart Twice Daily56.6
Secondary outcomeNumber· 26 weeks

Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)

GroupValue (Percentage of participants)
Exenatide Twice Daily1.8
Premixed Insulin Aspart Twice Daily6.3
Secondary outcomeNumber· 26 weeks

Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)

GroupValue (Percentage of participants)
Exenatide Twice Daily3.9
Premixed Insulin Aspart Twice Daily7.0
Secondary outcomeMean· Baseline and 26 weeks

7 Point Self-monitored Blood Glucose (SMBG) Profiles

GroupValue (mg/dL)Spread
Exenatide Twice Daily8.9331.7138
Premixed Insulin Aspart Twice Daily9.0052.0432
Secondary outcomeMean· Baseline and 26 weeks

Blood Lipid Levels

GroupValue (mmol/L)Spread
Exenatide Twice Daily5.1471.0008
Premixed Insulin Aspart Twice Daily5.0841.0079

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide Twice DailyExenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks–9 / 247102 / 247
Premixed Insulin Aspart Twice DailyPremixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks–8 / 23366 / 233

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 pageSee results (11)

Indexing hint: Randomized controlled trial · 2011

4 results

Exenatide twice daily versus premixed insulin aspart 70/30 in metformin-treated patients with type 2 diabetes: a randomized 26-week study on glycemic control and hypoglycemia.

Gallwitz et al. 2011Diabetes carecited by 78

PMID 21285388PMC3041190DOI 10.2337/dc10-1900PUB-21285388

Free to read · publisher termsCC BY-NC-ND4 results
Read at sourceSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 90 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start * Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start * Have an HbA1c between 6.5% and 10.0%, inclusive * Have a body mass index (BMI) between 25 kg/m\^2 and 40 kg/m\^2, inclusive Exclusion Criteria: * Have type 1 diabetes or known latent autoimmune diabetes in adults * Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start * Are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics) * Have used any prescription drug to promote weight loss within 3 months prior to study start * Have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry * Have previously completed or withdrawn from this study or any other study investigating exenatide or GLP-1 analogs

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