DPP-4 Inhibition, Incretins and Islet Function

NCT ID: NCT02089438

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-08-31

Brief Summary

Hypothesis is that DPP-4 inhibition affects glucose levels through changes in incretin and islet hormones. The study examines this in relation to breakfast, lunch and dinner over an entire 24h study period by the use of three different DPP-4 inhibitors and placebo.

Detailed Description

The study is a single-center study with a cross-over design to examine glycemia, incretin hormones and islet hormones over a 24h study period with standardized breakfast, lunch and dinner after administration of placebo, saxagliptin, vildagliptin or sitagliptin.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Saxagliptin

Ssaxagliptin is given before breakfast

Group Type: EXPERIMENTAL

Saxagliptin

Intervention Type: DRUG

Saxagliptin (5 mg) is given before breakfast

´Sitagliptin

Sitagliptin is given before breakfast

Group Type: EXPERIMENTAL

Sitagliptin

Intervention Type: DRUG

Sitagliptin (100 mg) is given before breakfast

Vildagliptin

Vildagliptin is given before breakfast

Group Type: EXPERIMENTAL

Vildagliptin

Intervention Type: DRUG

Vildagliptin (50mg) is given before breakfast and dinner

Interventions

Saxagliptin

Saxagliptin (5 mg) is given before breakfast

Intervention Type: DRUG

Vildagliptin

Vildagliptin (50mg) is given before breakfast and dinner

Intervention Type: DRUG

Sitagliptin

Sitagliptin (100 mg) is given before breakfast

Intervention Type: DRUG

Other Intervention Names

Onglyza; Galvus; Januvia

Eligibility Criteria

Inclusion Criteria

• • Caucasian men or women with type 2 diabetes diagnosed according to ICD10 at time of inclusion

• Ongoing treatment with life style adjustment including diet and exercise regimen together with metformin as oral antidiabetic . Metformin therapy should be stable the last three months
• Age 40-75 years
• HbA1c 52-80 mmol/mol (inclusive)
• BMI: 20-40 kg/m2
• Written informed consent has been given
• Capability and willingness to participate in the whole study

Exclusion Criteria

• • Liver disease (K70-77 in ICD10) or liver enzymes three times above upper reference range

• Diabetic nephropathy (GFR < 30 mL/min/1.73 m2 or albuminuria) or other causes of renal disease
• Proliferative diabetic retinopathy
• Treatment with any glucose-lowering medication except metformin
• Previous myocardial infarction, coronary heart disease or instable angina pectoris in the last 6 months.
• Symptomatic heart failure (NYHA class II-III)
• Previous surgery on the gastrointestinal tract
• Larger surgical intervention during the last 12 weeks
• Female subject who are pregnant or breast feeding
• Women of child bearing potential not using a highly effective method of birth control
• Treatment with oral steroids, thiazide diuretics, digoxin or growth hormone
• Hypersensitivity to the active substances of to any of the excipients
• Participation in another study the last 4 weeks
• Smoker
• Paracetamol intolerance

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Bo Ahren

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Ahrén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Clinical Research Department

Lund, , Sweden

Countries

Sweden

Other Identifiers

200A

Identifier Type: -

Identifier Source: org_study_id