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DPP-4 Inhibition, Incretins and Islet Function (CODI24)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Saxagliptin
Vildagliptin
Sitagliptin
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Saxagliptin

´Sitagliptin

Vildagliptin

Arm Description

Ssaxagliptin is given before breakfast

Sitagliptin is given before breakfast

Vildagliptin is given before breakfast

Outcomes

Primary Outcome Measures

Postprandial glucose
The area under the 180 min curves for plasma glucose after each meal

Secondary Outcome Measures

Postprandial insulin and glucagon
The area under the 180 min curves for plasma insulin and glucagon after each meal
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

Full Information

First Posted
March 14, 2014
Last Updated
August 22, 2017
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT02089438
Brief Title
DPP-4 Inhibition, Incretins and Islet Function
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saxagliptin
Arm Type
Experimental
Arm Description
Ssaxagliptin is given before breakfast
Arm Title
´Sitagliptin
Arm Type
Experimental
Arm Description
Sitagliptin is given before breakfast
Arm Title
Vildagliptin
Arm Type
Experimental
Arm Description
Vildagliptin is given before breakfast
Intervention Type
Drug
Intervention Name(s)
Saxagliptin
Other Intervention Name(s)
Onglyza
Intervention Description
Saxagliptin (5 mg) is given before breakfast
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Other Intervention Name(s)
Galvus
Intervention Description
Vildagliptin (50mg) is given before breakfast and dinner
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
Januvia
Intervention Description
Sitagliptin (100 mg) is given before breakfast
Primary Outcome Measure Information:
Title
Postprandial glucose
Description
The area under the 180 min curves for plasma glucose after each meal
Time Frame
180 min
Secondary Outcome Measure Information:
Title
Postprandial insulin and glucagon
Description
The area under the 180 min curves for plasma insulin and glucagon after each meal
Time Frame
180 min
Title
Postprandial glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)
Description
The area under the 180 min curves for plasma GLP-1 and GIP after each meal
Time Frame
180 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Ahrén, MD, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Department
City
Lund
ZIP/Postal Code
22185
Country
Sweden

12. IPD Sharing Statement

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DPP-4 Inhibition, Incretins and Islet Function

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