Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02832999
• Date of registration: 12/07/2016
• Prospective Registration: No
• Primary sponsor: Yaounde Central Hospital
• Public title: Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in Type 2 Diabetes LIRAVIS
• Scientific title: Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in a Sub Saharan African Population With Type 2 Diabetes
• Date of first enrolment: January 2016
• Target sample size: 14
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02832999
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: Phase 4

Countries of recruitment

Cameroon

Contacts

• Name: Eugène Sobngwi
• Affiliation: Yaounde Central Hospital

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Oral Vildagliptin

Drug: sub cutaneous liraglutide

Primary Outcome(s)

Insulin sentivity [Time Frame: 2 weeks]

Secondary Outcome(s)

body weight [Time Frame: 2 weeks]

insulin secretion [Time Frame: 2 weeks]

lipid profile [Time Frame: 2 weeks]

Secondary ID(s)

CNO20163

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Buea

University of Yaounde 1