NCT01787396

Brief Summary

The objective of this study is to evaluate efficacy and safety of initial combination therapy with Gemigliptin 50mg q.d and Metformin q.d compared with either monotherapy in treatment naïve patients with type 2 diabetes, In other words, to proof superiority of initial combination therapy with Gemigliptin and Metformin than each monotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
433

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2013

Typical duration for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

1.9 years

First QC Date

February 6, 2013

Last Update Submit

April 1, 2015

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Evaluation variables at week 24 to baseline(Visit 2(randomization), week 0)

    24weeks

Study Arms (3)

Arm1

EXPERIMENTAL

Gemigliptin 50mg + Metformin Once daily with dinner

Drug: Gemigliptin 50mgDrug: Metformin

Arm 2

EXPERIMENTAL

Gemigliptin 50mg + Placebo(Metformin)Once daily with dinner

Drug: Gemigliptin 50mgDrug: Placebo(Metformin)

Arm3

EXPERIMENTAL

Metformin+ Placebo(Gemigliptin 50mg)Once daily with dinner

Drug: MetforminDrug: Placebo(Gemigliptin)

Interventions

Gemigliptin 50mgDRUG
Arm 2Arm1
Placebo(Metformin)DRUG
Arm 2
MetforminDRUG
Arm1Arm3
Placebo(Gemigliptin)DRUG
Arm3

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes mellitus
  • Adults over 20 of age
  • Patients with hemoglobin A1c (HbA1c) over 7.5% at Visit1(screening) and no previous antidiabetic drugs before Visit 1(screening) or patients with hemoglobin A1c (HbA1c) between 7%\~10.5%, Patients treated with metformin monotherapy before Visit 1(screening).
  • Patients with no previous antidiabetic drugs
  • Patients with hemoglobin A1c (HbA1c) between 7.5%\~11% at Visit 2(randomization)

You may not qualify if:

  • Patients with type 1 diabetes mellitus Diabetic ketoacidosis or Hyperosmolar non-ketotic coma.
  • Patients with gestational diabetes, or secondary diabetes
  • Patients with New York Heart Association (NYHA) class III-IV congestive heart failure or patients with arrhythmia requiring treatment
  • Patients with dysfunctional thyroid gland (with abnormal level of TSH)
  • Patients with active bladder cancer.
  • Tests which need to be given radiation iodide dye by intravenous.(ex, intravenous urography, intravenous cholangiography, angiography, CT with dye)
  • Severe infection, pre or post operation.(Simple surgery which does not have restriction of food and fluid), severe trauma patient.
  • Patients with pituitary insufficiency or adrenal dysfunction.
  • Patients with pulmonary infarction, severe pulmonary dysfunction, hypoxemia.
  • Patients with gastrointestinal disorders(ex. Dehydration, Diarrhea, Vomiting)
  • Female patients who is gravida or in lactiferous phase or confirmed pregnancy by serum or urine.
  • Patients with body mass index (BMI) below 20 kg/m2 or exceeding 40 kg/m2
  • Male patients with Serum Creatinine level over 1.5mg/dl, Female patients with serum creatinine over 1.4mg/dl.
  • Patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST), exceeding 2.5 times or bilirubin exceeding 1.5 times of the upper limit of the normal range
  • Patients who were taking or needed to take any drugs that may affect the control of blood glucose significantly (ex. glucocorticoids)
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LG Life Sciences

Seoul, 110-062, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LC15-0444Metformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 8, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

KR(1)