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

Phase 2

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: Exenatide

• Registration Number: NCT01140893
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Study Start: 2010-11
• Status Verified: 2016-07
• Last Update Submitted: 2016-08-22
• Last Update Posted: 2016-08-23
• Primary Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	55 subjects
exenatide	Exenatide	55 subjects

Primary Outcome Measures

Name	Time	Method
Change from baseline to 6 months of centrally measured HbA1c	baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
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	occurrence of hyperglycemia above 190 mg/dl expressed as Area under the Curve (high) above 190 mg/dl (10.5 mmol/l), occurrence of hypoglycemia below 70 mg/dl (3.9 mmol/l) expressed as Area Under the Curve (low) below 70 mg/dl, glycemic variability (MAGE index).

Trial Locations

Locations (3)

Endocrinology Unit; 🇫🇷 Strasbourg, France

CERIDT; 🇫🇷 Corbeil-Essonne, France

Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen; 🇫🇷 Caen, France