NCT02049814

Brief Summary

The primary purpose of this study is to evaluate the efficacy of voglibose versus acarbose combined with metformin in participants with type 2 diabetes mellitus (T2DM) by evaluating levels of glycosylated hemoglobin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
494

participants targeted

Target at P75+ for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started May 2014

Typical duration for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

18 active sites

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

January 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 9, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

February 4, 2019

Completed
Last Updated

March 13, 2019

Status Verified

February 1, 2019

Enrollment Period

2.1 years

First QC Date

January 28, 2014

Results QC Date

August 13, 2018

Last Update Submit

February 15, 2019

Conditions

Type 2 Diabetes Mellitus

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12

    The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline.

    Baseline, Week 12

Secondary Outcomes (10)

  • Change From Baseline in HbA1c at Week 6

    Baseline and Week 6

  • Change From Baseline in Fasting Blood Glucose Over Time

    Baseline, Weeks 6 and 12

  • Change From Baseline in Postprandial Plasma Glucose (PPG) Over Time

    1 and 2 hours after meal at Baseline, Weeks 6 and 12

  • Change From Baseline in Fasting Insulin at Week 12

    Baseline, Week 12

  • Change From Baseline in Postprandial Serum Insulin at Week 12

    1 and 2 hours after meal at Baseline and Week 12

  • +5 more secondary outcomes

Study Arms (2)

Metformin + Voglibose 0.2 mg

EXPERIMENTAL

Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to voglibose 0.2 mg, tablets, orally, three times daily, for Weeks 1 and 2, followed by voglibose 0.3 mg, tablets, orally, three times daily, Weeks 3 through 12.

Drug: MetforminDrug: Voglibose

Metformin + Acarbose 50 mg

ACTIVE COMPARATOR

Metformin tablets, at the maximum tolerated dose ≥1000 mg/day, orally, for 12 weeks, in addition to acarbose 50 mg, tablets, orally, three times daily, Weeks 1 and 2, then acarbose 100 mg, tablets, orally, three times daily, Weeks 3 through 12.

Drug: MetforminDrug: Acarbose

Interventions

MetforminDRUG

Metformin tablets

Also known as: Glucophage
Metformin + Acarbose 50 mgMetformin + Voglibose 0.2 mg
VogliboseDRUG

Voglibose tablets

Also known as: Basen
Metformin + Voglibose 0.2 mg
AcarboseDRUG

Acarbose tablets

Also known as: Glucobay, Precose, Prandase
Metformin + Acarbose 50 mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has a historical diagnosis of type 2 diabetes mellitus (T2DM) for at least 6 months prior to the screening visit (V1).
  • Is male or female and aged from 18 to 75 years, inclusively.
  • Has a body mass index (BMI) between 20 and 45 kg/m\^2, inclusively.
  • Is experiencing inadequate glycemic control with a glycosylated hemoglobin (HbA1c) concentration between 7.0% and 10.0%, inclusively.
  • Has been treated with Metformin for at least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to Screening, unless there is documentation that the participant's current dose is his or her maximum tolerated dose (MTD) and MTD is ≤1000 mg/day.
  • Keeps constant body weight with fluctuation range no more than 10% over for at least 3 months before screening.
  • Hemoglobin levels of the participant are ≥12 g/dL (≥120 g/L) in male and≥ 10 g/dL (≥100 g/L) in female at screening visit.
  • Male serum creatinine \<1.5 mg/dL and female serum creatinine \<1.4 mg/dL, or estimated glomerular filtration rate (eGFR) \>60 ml/min/1.73m\^2 based on calculation using the Modification of Diet in Renal Disease (MDRD) approximation at Screening.
  • In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  • The participant or, when applicable, the participant's legally acceptable representative signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.

You may not qualify if:

  • Type 1 diabetes mellitus.
  • Has received insulin, voglibose, acarbose or other oral hypoglycemic drugs (except Metformin) for accumulative total of more than 7 days within the latest 3 months prior to Visit 1.
  • Has a history of cardiovascular disease: acute myocardial infarction, class III or IV heart failure, or cerebrovascular accident (stroke) within the latest 3 months prior to Visit 1.
  • The participant's liver function is damaged and has a significant clinical sign or symptom of hepatopathy, acute or chronic hepatitis, or the value of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is 3 times more than the upper limit of normal level at Visit 1.
  • Has an active proliferative retinopathy or macular degeneration that need to have an urgent treatment in the opinion of investigators.
  • Has a frequent attack of hypoglycemia or loses consciousness due to hypoglycemia in the opinion of investigators.
  • Has one or more times ketoacidosis or hyperosmotic status/coma.
  • Is receiving long-term (\>14days) systemic glucocorticoid treatment (except the medicine: local, intraocular, inhalation or via the nose) or has received such treatment for 4 weeks at Visit 1.
  • Has a hematopathy (e.g. hemolytic anemia, drepanocytosis) that may interfere with the HbA1c test.
  • Has other liabilities (e.g. drug abuse, alcoholism or mental disorder) that may hinder the participant to follow and complete the study.
  • Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization.
  • Is unsuitable for this study in the opinion of investigators.
  • Has a disease need to use other taboo or caution drugs that is not listed in this study.
  • If female, is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Hefei, Anhui, China

Location

Unknown Facility

Maanshan, Anhui, China

Location

Unknown Facility

Beijing, Beijing Municipality, China

Location

Unknown Facility

Guangzhou, Guangdong, China

Location

Unknown Facility

Shenzhen, Guangdong, China

Location

Unknown Facility

Taishan, Guangdong, China

Location

Unknown Facility

Zhuzhou, Hunan, China

Location

Unknown Facility

Nanjing, Jiangsu, China

Location

Unknown Facility

Xuzhou, Jiangsu, China

Location

Unknown Facility

Changchun, Jilin, China

Location

Unknown Facility

Jilin, Jilin, China

Location

Unknown Facility

Shenyang, Liaoning, China

Location

Unknown Facility

Qingdao, Shandong, China

Location

Unknown Facility

Shanghai, Shanghai Municipality, China

Location

Unknown Facility

Yanan, Shanxi, China

Location

Unknown Facility

Yan’an, Shanxi, China

Location

Unknown Facility

Tianjin, Tianjin Municipality, China

Location

Unknown Facility

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

MetforminvogliboseAcarbose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsTrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Medical Director, Clinical Science

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 30, 2014

Study Start

May 9, 2014

Primary Completion

June 1, 2016

Study Completion

June 28, 2016

Last Updated

March 13, 2019

Results First Posted

February 4, 2019

Record last verified: 2019-02

Locations

CN(18)