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OpenTrials
Completed

NCT Number: NCT00369148

Combination of Glinides With Premixed Insulin

Combination therapy of glinides with premixed insulin provides better glycemic control than premixed insulin alone.

Completed

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Key information

Conditions

Type 2 Diabets Mellitus

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nippon Kokan Hospital, Kawasaki, Kanagawa, Japan

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About this study

Type 2 diabetic patients undergoing twice daily injections of premixed insulin are administered glinides (10mg of mitiglinide or 90 mg of nateglinide) at lunchtime without changing their insulin regimen. Twelve weeks after administration of the glinides, they are discontinued. HbA1c levels at the start of glinide administration, 12 weeks after administration, and 12 weeks after discontinuation are measured.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of type 2 diabetes
  • Who undergoes twice daily injection of premixed insulin
  • Whose HbA1c is more than 6.5% and less than 8.0%

Exclusion criteria

  • Whose change of HbA1c is more than 1.0% during 12 weeks observational period

Treatment and study plan

nateglinide(drug) mitiglinide(drug)

Drug

Primary outcomes

  1. glycohemoglobin

Secondary outcomes

  1. anhydroglucitol

  2. lipid profile

  3. body weight

  4. blood pressure

Sponsors and collaborators

Lead sponsor

Keio University

Other

Registry information

Official study title

Evaluation of Usefulness of Combination Therapy of Rapid Acting Insulin Secretagogue (Glinide) With Premixed Insulin in Type 2 Diabetes

Important dates

Study start
2004
Study completion
2006
First posted
Aug 29, 2006
Registry last updated
Aug 26, 2009

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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