NCT00935532

Brief Summary

The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
427

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2009

Typical duration for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 24, 2012

Completed
Last Updated

June 15, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

July 8, 2009

Results QC Date

February 14, 2012

Last Update Submit

May 21, 2015

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes; exenatide once weekly; Byetta; glargine; Lantus; Amylin; Lilly

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c From Baseline to Endpoint (Week 26)

    Change in HbA1c from baseline to endpoint (Week 26).

    Baseline, Week 26

Secondary Outcomes (10)

  • Percentage of Subjects Achieving HbA1c<=7%

    Baseline, Week 26

  • Percentage of Subjects Achieving HbA1c<=6.5%

    Baseline, Week 26

  • Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)

    Baseline, Week 26

  • Change in Body Weight From Baseline to Endpoint (Week 26)

    Baseline, Week 26

  • Change in Total Cholesterol From Baseline to Endpoint (Week 26)

    Baseline, Week 26

  • +5 more secondary outcomes

Study Arms (2)

exenatide once weekly

EXPERIMENTAL
Drug: exenatide once weekly

insulin glargine

ACTIVE COMPARATOR
Drug: insulin glargine

Interventions

exenatide once weeklyDRUG

subcutaneous injection, 2.0mg, once a week;

exenatide once weekly
insulin glargineDRUG

subcutaneous injection, titrated to achieve fasting serum glucose target, once a day

Also known as: insulin glargine-Lantus
insulin glargine

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • present with type 2 diabetes mellitus
  • HbA1c between 7.1% and 11.0% inclusive
  • body mass index (BMI) of \>18kg/m2 and \<35kg/m2, inclusive
  • treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start

You may not qualify if:

  • Have received chronic (\>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start.
  • Have been treated with drugs that promote weight loss within 90 days prior to study start.
  • Have been treated with drugs that directly affect gastrointestinal motility for \> 21 consecutive days within 90 days prior to study start.
  • Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered).
  • Have been treated for \>2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs
  • Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.
  • Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start.
  • Have donated blood within 30 days prior to study start.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Research Site

Aomori, Japan

Location

Research Site

Chiba, Japan

Location

Research Site

Ehime, Japan

Location

Research Site

Fukuoka, Japan

Location

Research Site

Gunma, Japan

Location

Research Site

Hiroshima, Japan

Location

Research Site

Hokkaido, Japan

Location

Research Site

Hyōgo, Japan

Location

Research Site

Ibaraki, Japan

Location

Research Site

Kagawa, Japan

Location

Research Site

Kanagawa, Japan

Location

Research Site

Kumamoto, Japan

Location

Research Site

Kyoto, Japan

Location

Research Site

Nagano, Japan

Location

Research Site

Nagasaki, Japan

Location

Research Site

Nara, Japan

Location

Research Site

Osaka, Japan

Location

Research Site

Ōita, Japan

Location

Research Site

Saitama, Japan

Location

Research Site

Shizuoka, Japan

Location

Research Site

Tokyo, Japan

Location

Research Site

Toyama, Japan

Location

Related Publications (2)

  • Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18.

    PMID: 32306296DERIVED

  • Inagaki N, Atsumi Y, Oura T, Saito H, Imaoka T. Efficacy and safety profile of exenatide once weekly compared with insulin once daily in Japanese patients with type 2 diabetes treated with oral antidiabetes drug(s): results from a 26-week, randomized, open-label, parallel-group, multicenter, noninferiority study. Clin Ther. 2012 Sep;34(9):1892-908.e1. doi: 10.1016/j.clinthera.2012.07.007. Epub 2012 Aug 9.

    PMID: 22884767DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Peter Ohman, Medical Science Director
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Chief Medical Officer, MD

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2009

First Posted

July 9, 2009

Study Start

July 1, 2009

Primary Completion

September 1, 2010

Study Completion

July 1, 2011

Last Updated

June 15, 2015

Results First Posted

October 24, 2012

Record last verified: 2015-05

Locations

JP(22)