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Completed

NCT Number: NCT02089438

DPP-4 Inhibition, Incretins and Islet Function

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Research Department

Lund, 22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saxagliptin

Drug

Saxagliptin (5 mg) is given before breakfast

Other names: Onglyza

Vildagliptin

Drug

Vildagliptin (50mg) is given before breakfast and dinner

Other names: Galvus

Sitagliptin

Drug

Sitagliptin (100 mg) is given before breakfast

Other names: Januvia

Primary outcomes

  1. Postprandial glucose

    Time frame: 180 min

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

Secondary outcomes

  1. Postprandial insulin and glucagon

    Time frame: 180 min

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

  2. Postprandial glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)

    Time frame: 180 min

    The area under the 180 min curves for plasma GLP-1 and GIP after each meal

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

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

Acronym: CODI24

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2014
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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