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

Caen University Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Exenatide; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01140893

EudraCT N° 2009-016384-11

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

exenatide

Experimental group

Description:

55 subjects

Treatment:

Drug: Exenatide

Placebo

Placebo Comparator group

Description:

55 subjects

Treatment:

Drug: Placebo