Clinical trial NCT01140893: Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes
Official title: Effects of EXEnatide on Glycemic Control and Weight Over 26 Weeks in Continuous Subcutaneous Insulin Infusion (CSII) Treated Patients With Type 2 Diabetes : a Phase 2/3 Double Blind randoMized Placebo-controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
CSII
Exenatide
Double Blind Placebo Controlled Study
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2010-06-10
Enrollment: 110
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline to 6 months of centrally measured HbA1c
timeFrame: baseline to 6 months
Secondary outcomes:
measure: 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
timeFrame: baseline to 6 months
measure: Change from baseline in mean blood glucose value
timeFrame: baseline to 6 months
Other outcomes:
Locations:
city: Caen
country: France
facility: Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
city: Corbeil-Essonne
country: France
facility: CERIDT
city: Strasbourg
country: France
facility: Endocrinology Unit
Study officials:
affiliation: Endocrinology Unit, University Hospital of Caen, FRANCE
name: Michael JOUBERT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrinology Unit, University Hospital of Caen, FRANCE
name: Yves REZNIK, MD
role: PRINCIPAL_INVESTIGATOR
References: