Clinical trial NCT02832999: Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in Type 2 Diabetes
Official title: Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in a Sub Saharan African Population With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
GLP-1
Insulin secretion
insulin sensitivity
Africa
Liraglutide
Vildaglipin
Lead sponsor: Yaounde Central Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Yaounde 1
name: University of Buea
First posted: 2016-07-14
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single blind randomised controlled clinical trial in uncontrolled type 2 Diabetes mellitus patients on oral glucose lowering agents, and naive to incretinomimetic. Participants will be randomised in two Arms : arm 1 receiving Liraglutide at 1,2 mg/day and arm 2 Vildagliptine at 100mg/day over 14 days. The two arms will be compared for 14-day changes in insulin secretion and insulin sensitivity.

Detailed description: Incretinomimetics include exogenous Glucagon-Like Peptide analogs (GLP1a) such as Liraglutide, and inhibitors of Dipeptidyl peptidase IV (DPP4i) that prolong the half-life of endogenous GLP1 such as Vildagliptin. It remains unclear which of the two strategies (exogenous GLP1 or prolonging half-life of endogenous GLP1) have better short term effect on insulin sensitivity and insulin secretion in people living with type 2 diabetes.

This study aims to investigate the short-term metabolic effects of a GLP-1 analog Liraglutide versus a DPP4i Vildagliptin. It is a randomized, controlled, single-blinded clinical trial. Study population consists of uncontrolled type 2 diabetes mellitus patients (HbA1c≥7%) under mono or bi oral anti-diabetic therapy, naïve of any incretinomimetic treatment. Participants are randomized in 2 arms. The intervention in arm 1 consists of add-on subcutaneous Liraglutide at 0.6mg/day for 1 week increased to 1.2mg the second week. In the second arm, it consists of oral Vildagliptine at 100mg daily for two weeks. The primary outcome is the variation in euglycaemic hyperinsulinaemic clamp-derived insulin sensitivity before randomization and the day after intervention, secondary outcomes include 14-day changes in insulin secretion during a mixed meal tolarance test, body weight and body composition, and an indirect calorimetry measured resting energy expenditure. Changes from baseline to 14 days in serum creatinine and alanine amino transferase, C-reactive protein and lipid profile will also be recorded.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus known for at least one year
* Uncontrolled glycaemic profile with HbA1c ≥ 7% on oral antidiabetic mono or bi-therapy
* Naïve of incretinomimetic treatment
* Informed consent

Exclusion Criteria:

* Change in antidiabetic treatment less than 3 months prior to inclusion
* Pancreatitis
* Alanine amino transferase \> 3 times the normal values
* Pregnant or breastfeeding women
* Estimated glomerular filtration rate \< 60ml/min
* Infection less than 10 days prior to inclusion or during the study
* Acute complication of diabetes
* Total haemoglobin \< 11g/dL in women or \< 13g/dL in men
* Withdrawal of consent

Primary outcomes:
measure: Insulin sentivity
timeFrame: 2 weeks
Secondary outcomes:
measure: insulin secretion
timeFrame: 2 weeks
measure: lipid profile
timeFrame: 2 weeks
measure: body weight
timeFrame: 2 weeks
Other outcomes:
measure: Renal function
timeFrame: 2 weeks
measure: Inflammation
timeFrame: 2 weeks
Locations:
city: Yaounde
country: Cameroon
facility: National Obesity Centre
Study officials:
affiliation: Yaounde Central Hospital
name: Eugène Sobngwi
role: PRINCIPAL_INVESTIGATOR
References: