DPP-4 Inhibition, Incretins and Islet Function

Type 2 Diabetes Clinical Trial

— CODI24  

Official title:

Comparison of Three DPP-4 Inhibitors on 24 Hour Blood Glucose, Incretin Hormones and Islet Function in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089438
• Other study ID #: 200A
• Status: Completed
• Phase: Phase 4
• First received: March 14, 2014
• Last updated: August 22, 2017
• Start date: May 2014
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Saxagliptin
Saxagliptin (5 mg) is given before breakfast
• Vildagliptin
Vildagliptin (50mg) is given before breakfast and dinner
• Sitagliptin
Sitagliptin (100 mg) is given before breakfast

Locations

Country	Name	City	State
Sweden	Clinical Research Department	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glucose	The area under the 180 min curves for plasma glucose after each meal	180 min
Secondary	Postprandial insulin and glucagon	The area under the 180 min curves for plasma insulin and glucagon after each meal	180 min
Secondary	Postprandial glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)	The area under the 180 min curves for plasma GLP-1 and GIP after each meal	180 min