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Trial · Interventional

CompletedPhase 3Registry data

Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

NCTNCT00359879 (opens ClinicalTrials.gov in a new tab)Other idH8O-CR-GWBH
Open at ClinicalTrials.govAsk about this trial

Overview

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

Brazil, Mexico

Start
Sept 2006
Primary completion
Jul 2007
Completion
Jul 2007
First posted
3 Aug 2006 (estimated)
Last update posted
23 Feb 2015 (estimated)
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200620072008
  1. Ph 3

    Comparison of Exenatide Taken Before Lunch and Dinner With Before Breakfast and Dinner in Patients With Type 2 Diabetes

    NCT00359879

    Sept 2006 to Jul 2007

Registry summary

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

This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.

Interventions

  • exenatideDrug
  • exenatideDrug

Arms2

  • Experimental

    1 - exenatide before breakfast and dinner

  • Active comparator

    2 - exenatide before lunch and dinner

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12

    Time frame · Baseline, Week 12

    Registry description

    Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12

Secondary outcomes(3)

  1. Change in body weight from Baseline to Week 12, and if measured, at each visit

    Time frame · Baseline, Weeks 4, 8, 12

    Registry description

    Change in body weight (kg) from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)

  2. Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit

    Time frame · Baseline, Weeks 4, 8, 12

    Registry description

    Change in FGS from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8)

  3. Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12

    Time frame · Baseline, Weeks 4, 8, 12

    Registry description

    Changes in glucose measured at different times throughout the day derived from 7-point SMBG profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime)

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

9 results

Efficacy and safety of exenatide administered before the two largest daily meals of Latin American patients with type 2 diabetes.

Forti et al. 2008Current medical research and opinioncited by 14

PMID 18662495DOI 10.1185/03007990802282398PUB-18662495

Full text at the publisher9 results
Publisher pageSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Diagnosed with type 2 diabetes. * Have been treated with one of the following treatment regimens for at least three months prior to screening: \*metformin alone; \*sulfonylurea (SU) alone; \*thiazolidinedione (TZD) alone; \*a combination of metformin and SU; \*a combination of metformin and TZD. * HbA1c between 7.1% and 10.0%, inclusive. * Body Mass Index (BMI) \> 25 kg/m\^2 and \< 45 kg/m\^2 Exclusion Criteria: * Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental drug, medical, or surgical treatment was given) within 30 days prior to screening. * Have characteristics contraindicating metformin, SU, or TZD use. * 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. * Have used any prescription drug to promote weight loss within 3 months prior to screening. * Are currently treated (for greater than 2 consecutive weeks) with any of the following excluded medications: \*insulin within 3 months prior to screening; \*alpha-glucosidase inhibitors within 3 months prior to screening; \*meglitinides within 3 months prior to screening; \*drugs that directly affect gastrointestinal motility

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