Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes

NCT ID: NCT01140893

Last Updated: 2016-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

exenatide

55 subjects

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

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.

Placebo

55 subjects

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Exenatide

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.

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Exenatide = BYETTA (R)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Type 1 diabetes assessed by positive anti-GAD65 or anti-insulin or anti-IA2 antibodies
• Monogenic diabetes (MODY, mitochondrial diabetes…)
• Current treatment with OHA (OHA ought to be interrupted at least two months prior to inclusion in the study)
• Current treatment specifically addressed for weight lost (orlistat, sibutramine, rimonabant may be interrupted at least 3 months prior to inclusion in the study)
• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael JOUBERT, MD

Role: PRINCIPAL_INVESTIGATOR

Endocrinology Unit, University Hospital of Caen, FRANCE

Yves REZNIK, MD

Role: PRINCIPAL_INVESTIGATOR

Endocrinology Unit, University Hospital of Caen, FRANCE

Locations

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

Caen, , France

Site Status: RECRUITING

CERIDT

Corbeil-Essonne, , France

Site Status: RECRUITING

Endocrinology Unit

Strasbourg, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Michael Joubert, MD

Role: CONTACT

joubert-m@chu-caen.fr

Yves Reznik, MD

Role: CONTACT

reznik-y@chu-caen.fr

Facility Contacts

Role: primary

+33 2 31 06 45 75

Guillaume Charpentier, MD

Role: primary

Nathalie Jeandidier, MD, PhD

Role: primary

Other Identifiers

EudraCT N° 2009-016384-11

Identifier Type: -

Identifier Source: org_study_id