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OpenTrials
Completed

NCT Number: NCT02126358

Gemigliptin-Rosuvastatin Fix-dose Combination Phase 3(BALANCE)

To evaluate the efficacy and safety of the fix-dose combination therapy with Gemigliptin 50mg and Rosuvastatin 20mg with type 2 diabetes and dyslipidemia

Completed

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Severance hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 Diabetes Mellitus with Dyslipidemia
  • Adults who are at least 19 years old

Exclusion criteria

  • Patients with type 1 diabetes, diabetic ketoacidosis, diabetic coma and pre-coma
  • Patients with gestational diabetes or secondary diabetes
  • Patients with NYHA Class III, IV congestive heart failure or arrhythmias requiring treatment
  • Patients with thyroid gland dysfunction deviating from the normal TSH range
  • Patients with pituitary insufficiency or adrenal insufficiency

Treatment and study plan

Gemigliptin and/or Rosuvastatin

Drug

Primary outcomes

  1. HbA1c change

    Time frame: Baseline(Day 0) to Treatment (last visit, w24)

  2. LDL-C change rate

    Time frame: Baseline(Day 0) to Treatment (last visit, w24)

Secondary outcomes

  1. HbA1c

    Time frame: Baseline(Day 0) to Treatment (last visit, w24)

    (Gemigliptin/Rosuvastatin FDC vs. Gemigliptin)

  2. LDL-C change rate

    Time frame: Baseline(Day 0) to Treatment (last visit, w24)

    (Gemigliptin/Rosuvastatin FDC vs. Rosuvastatin)

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy and Safety of the Fix-dose Combination Therapy With Gemigliptin 50mg and Rosuvastatin 20mg With Type 2 Diabetes and Dyslipidemia

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 30, 2014
Registry last updated
Oct 18, 2016

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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