Study of the Effect of Vildagliptin versus Dapagliflozin on Glucagon Response to Mixed Meal in Metformin-treated Subjects with Type 2 Diabetes

Phase 1

• Conditions: Type 2 Diabetes Mellitus; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-001334-21-SE
• Lead Sponsor: und University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-17
• Last Update Posted: 24 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Written consent has been given.
2. Patients with type 2 diabetes treated with a stable dose of metformin
3. Age 20-70 years.
4. HbA1c 6.5-8.5% (48-67 mmol/mol) at visit 1.
5. Ability to complete the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1.Use of other glucose-lowering therapy than metformin within three months prior to visit 1.
2.A history of any secondary forms of diabetes, e.g., Cushing’s syndrome and acromegaly.
3.Type 1 diabetes, positive GAD antibodies
4.eGFR <60 ml/min
5.Acute infections which may affect blood glucose control within 4 weeks prior to visit 1
6.Any history of recent (<2 weeks) recurrent or severe hypoglycemic episodes.
7.Any history of acute pancreatitis
8.Any history of anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
9.Liver disease such as cirrhosis or chronic active hepatitis
10.History of coronary heart disease or heart failure class III or IV
11.Donation of one unit (500 ml) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks.
12.Treatment with growth hormone of chronic oral or parenteral corticosteroid treatment (> 7 consecutive days of treatment) within 8 weeks prior to visit 1.
13.Use of other investigational drugs at visit 1 or within 30 days of visit 1, unsuitable for the study
14.Hypersensitivity to vildagliptin or dapagliflozin or any compound in the tablet core

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effects of vildagliptin versus dapagliflozin on glucagon response to mixed meal ingestion in metformin-treated patients with type 2 diabetes ;Secondary Objective: To compare the effects of vildagliptin versus dapagliflozin oninsulin secretion after mixed meal ingestion in metformin-treated patients with type 2 diabe;Primary end point(s): The effect of vildagliptin and daspagliflozin on the area under the curve (AUC) of the 180 min glucagon levels after mixed meal ingestion;Timepoint(s) of evaluation of this end point: 4 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The effect of vildagliptin and dapagliflozin on 180 min area under the curve of GLP-1, GIP, insulin, C-peptide and estimated ISR (insulin secretory rate). ;Timepoint(s) of evaluation of this end point: 2 weeks