Short Term Effect of Liraglutide Versus Vildagliptine on Insulin Secretion and Insulin Sensitivity in Type 2 Diabetes
NCT ID: NCT02832999
Last Updated: 2017-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
14 participants
INTERVENTIONAL
2016-01-31
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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sub cutaneous liraglutide
once daily add-on subcutaneous injection of Liraglutide at 0.6mg/day for 1 week increased to 1.2mg the second week
sub cutaneous liraglutide
Liraglutide 1.2mg/day
Oral Vildagliptin
Once daily oral 100mg of Vildagliptine for two weeks
Oral Vildagliptin
Vildagliptin 50mg/day
Interventions
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sub cutaneous liraglutide
Liraglutide 1.2mg/day
Oral Vildagliptin
Vildagliptin 50mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Uncontrolled glycaemic profile with HbA1c ≥ 7% on oral antidiabetic mono or bi-therapy
* Naïve of incretinomimetic treatment
* Informed consent
Exclusion Criteria
* 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
21 Years
70 Years
ALL
No
Sponsors
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University of Yaounde 1
OTHER
University of Buea
OTHER
Yaounde Central Hospital
OTHER_GOV
Responsible Party
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Sobngwi Eugene
Professor of Endocrinology and Diabetes
Principal Investigators
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Eugène Sobngwi
Role: PRINCIPAL_INVESTIGATOR
Yaounde Central Hospital
Locations
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National Obesity Centre
Yaoundé, , Cameroon
Countries
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Other Identifiers
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CNO20163
Identifier Type: -
Identifier Source: org_study_id