NCT01140893

Brief Summary

The purpose of this study is to determine whether exenatide is effective to improve glycemic control among type 2 diabetic patients treated by insulin pump therapy.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes

Geographic Reach
1 country

3 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 3, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Last Updated

August 23, 2016

Status Verified

July 1, 2016

Enrollment Period

6.5 years

First QC Date

May 3, 2010

Last Update Submit

August 22, 2016

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetesCSIIExenatideDouble Blind Placebo Controlled Study

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to 6 months of centrally measured HbA1c

    baseline to 6 months

Secondary Outcomes (2)

  • Change from baseline in weight, BMI, waist circumference, 6 points glucose profile, insulin doses, % of daily use of insulin as basal rate, % of daily use of insulin as bolus, quality of life questionnaire

    baseline to 6 months

  • Change from baseline in mean blood glucose value

    baseline to 6 months

Study Arms (2)

exenatide

EXPERIMENTAL

55 subjects

Drug: Exenatide

Placebo

PLACEBO COMPARATOR

55 subjects

Drug: Placebo

Interventions

ExenatideDRUG

Research drug (exenatide or placebo), will begin at V0, after randomization. The initial dosage for the first month will be 5 µg SC BID. Injections can be administered at any time within the 60 minute period before the morning and evening meal. From V1, research drug will be titrated from 5 to 10 µg SC BID. If gastro-intestinal adverse effects occur with 10 µg SC BID, the dosage will be back-titrated to 5 µg SC BID. Thus, the higher research drug dosage tolerated will be used during the study time.

Also known as: Exenatide = BYETTA (R)
exenatide
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women aged 35 to 70
  • Type 2 diabetes diagnosed for at least 12 months, according the criteria of the American Diabetes Association :
  • presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2-hour post-prandial or random glucose \>200 mg/dL) or
  • fasting plasma glucose elevation on more than 1 occasion \> 125 mg/dL or
  • patient currently undergoing pharmacological and/or non-pharmacological treatment for diabetes mellitus
  • CSII treatment using a rapid analog for at least 6 month (CSII being initiated in patients with HbA1c \> 8 % despite a well-conducted MDI trial using a 2 to 5 daily injection regimen)
  • HbA1c ≥ 7,5% and ≤ 10 %
  • BMI ≥ 25 and ≤ 45
  • Stable body weight (≤10% variation) during the 3 last months

You may not qualify if:

  • Type 1 diabetes assessed by positive anti-GAD65 or anti-insulin or anti-IA2 antibodies
  • Monogenic diabetes (MODY, mitochondrial diabetes…)
  • Use of corticosteroid therapy for more than 10 days within the 3-past months, or patient who ought to be treated by corticosteroid during the study period
  • Clinically significant hepatic disease
  • Documented gastroparesis, or current use of drugs that directly affect gastrointestinal motility, or any significant abdominal disease that may increase the risk of adverse gastrointestinal effects induced by exenatide
  • Kidney failure (MDRD less than 50 ml/min)
  • Pregnancy/breastfeeding
  • Any social and/or mental condition rendering the subject unable to understand the scope and possible consequences of the study
  • Concurrent enrolment in another clinical trial
  • Geographically inaccessible for follow-up visits required by protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen

Caen, 14000, France

RECRUITING

CERIDT

Corbeil-Essonne, France

RECRUITING

Endocrinology Unit

Strasbourg, France

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • Michael JOUBERT, MD

    Endocrinology Unit, University Hospital of Caen, FRANCE

    PRINCIPAL INVESTIGATOR

  • Yves REZNIK, MD

    Endocrinology Unit, University Hospital of Caen, FRANCE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Joubert, MD

CONTACT

joubert-m@chu-caen.fr

Yves Reznik, MD

CONTACT

reznik-y@chu-caen.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2010

First Posted

June 10, 2010

Study Start

November 1, 2010

Primary Completion

May 1, 2017

Last Updated

August 23, 2016

Record last verified: 2016-07

Locations

FR(3)