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OpenTrials
Completed

NCT Number: NCT01422590

Pharmacodynamics of Mitiglinide/Sitagliptin Compared to Mitiglinide and Sitagliptin

1. Explore pharmacodynamics

* glucose * insulin * C-peptide * glucagon * intact GLP-1 * DPP-4 activity * CGMS (continuous glucose monitoring system) 2. Assess Safety

* adverse events * clinical laboratory test * physical examination

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

Pharmacodynamic assessment

  • CGMS data is obtained from day 1 to day 3 (48 hours)
  • PD is measured before (day 1) and after drug administration (day 2)
  • AUC of glucose, insulin, C-peptide, glucagon, intact GLP-1, DPP-4 activity
  • MAGE (mean amplitude of glycemic excursion) from CGMS data

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients with type 2 diabetes mellitus
  • 6.5% ≤ HbA1c < 9.0%
  • Stopped treatment of sulfonylurea and biguanide for more than 8 weeks
  • Stopped treatment of other anti-diabetic agents for more than 12 weeks
  • 16 kg/m2 ≤ body mass index < 30 kg/m2

Exclusion criteria

  • Fasting glucose ≥ 200 mg/dL
  • Required insulin therapy
  • Patients with neuropathy, retinopathy or renopathy
  • Contraindicated for mitiglinide or sitagliptin

Treatment and study plan

Sitagliptin

Drug

Single oral administration of sitagliptin 100 mg

Mitiglinide

Drug

Single oral administration of mitiglinide 10 mg

Sitagliptin, Mitiglinide

Drug

Concomitant administration of sitagliptin 100 mg and mitiglinide 10 mg

Primary outcomes

  1. AUC (area under the curve) of plasma glucose

    Time frame: day 1 and day 2 of each period

    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

  2. AUC of insulin

    Time frame: day 1 and day 2 of each period

    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

  3. AUC of intact GLP-1

    Time frame: day 1 and day 2 of each period

    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

  4. AUC of C-peptide

    Time frame: day 1 and day 2 of each period

    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

  5. AUC of glucagon

    Time frame: day 1 and day 2 of each period

    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

  6. MAGE

    Time frame: day 1 and day 2 of each period

    Differences of MAGE before treatment (day 1) and after treatment (day 2) is compared between treatment groups

  7. AUC of DPP-4 activity

    Time frame: day 1 and day 2 of each period

    Differences of AUC before treatment (day 1) and after treatment (day 2) is compared between treatment groups

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • JW Pharmaceutical

Registry information

Official study title

Pharmacodynamics After Concomitant Administration With Mitiglinide and Sitagliptin Compared to Mitiglinide, Sitagliptin Single Administration in Patients With Type 2 Diabetes

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 24, 2011
Registry last updated
Sep 7, 2011

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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