Efficacy and Safety of Voglibose Compared With Acarbose in Patients With Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02049814
First received: January 28, 2014
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Metformin
Drug: Voglibose
Drug: Acarbose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Voglibose Compared With Acarbose in Patients With Type 2 Diabetes Inadequately Controlled on Metformin Alone: a Randomized, Open-label, Non-inferiority Study

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 and glycosylated hemoglobin collected at baseline.


Secondary Outcome Measures:
  • Change From Baseline in HbA1c at Weeks 2 and 6. [ Time Frame: Baseline and Weeks 2 and 6 ] [ Designated as safety issue: No ]
    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 Weeks 2 and 6 and glycosylated hemoglobin collected at Baseline.

  • Change From Baseline in Fasting Blood Glucose Over Time [ Time Frame: Baseline and Weeks 2, 6 and 12 ] [ Designated as safety issue: No ]
    The change between the value of fasting blood glucose collected at Weeks 2, 6 and 12 and fasting blood glucose collected at Baseline.

  • Change from Baseline in Postprandial Blood Glucose Over Time [ Time Frame: Baseline and Weeks 2, 6 and 12 ] [ Designated as safety issue: No ]
    The change from Baseline in postprandial blood glucose, collected at one and two hours after a meal.

  • Change From Baseline in Fasting Insulin at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change between the value of fasting insulin collected at Week 12 and fasting insulin collected at Baseline.

  • Change from Baseline in Postprandial Serum Insulin at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from Baseline in postprandial serum insulin, collected at one and two hours after a meal.

  • Change From Baseline in Fasting Glucagon at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change between the value of fasting glucagon collected at Week 12 and fasting glucagon collected at Baseline.

  • Change from Baseline in Postprandial Serum Glucagon at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change from Baseline in postprandial serum glucagon collected at one and two hours after a meal.

  • Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change between the value of HOMA-IR collected at Week 12 and HOMA-IR collected at Baseline. HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater insulin resistance.

  • Change From Baseline in Insulin Homeostatic Model Assessment (HOMA) Beta Cell Function at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    The change between the value of HOMA-beta cell function collected at Week 12 and HOMA-beta cell function collected at Baseline. The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5.

  • Change From Baseline in Body Weight Over Time [ Time Frame: Baseline and Weeks 2, 6 and 12 ] [ Designated as safety issue: No ]
    The change between body weight at Weeks 2, 6 and 12 and body weight at Baseline.


Estimated Enrollment: 380
Study Start Date: June 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin + Voglibose
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: Metformin
Metformin tablets
Other Name: Glucophage
Drug: Voglibose
Voglibose tablets
Other Name: Basen
Active Comparator: Metformin + Acarbose
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: Metformin
Metformin tablets
Other Name: Glucophage
Drug: Acarbose
Acarbose tablets
Other Name: Glucobay, Precose, Prandase

Detailed Description:

The drug being tested in this study is called voglibose. Voglibose is being tested to treat type 2 diabetes in people who have diabetes that is inadequately controlled on metformin alone. This study will look at glycemic control in people who take voglibose.

The study will enroll approximately 380 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

  • Metformin maximum tolerated dose and voglibose 0.2 mg for 2 weeks followed by 0.3 mg for 10 weeks
  • Metformin maximum tolerated dose and acarbose 50 mg for 2 weeks followed by 100 mg for 10 weeks.

All participants will be asked to take their current dose of metformin tablets and either voglibose or acarbose tablets three times a day throughout the study.

This multi-centre trial will be conducted in China. The overall time to participate in this study is up to 20 weeks and participants will make 8 visits to the clinic.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has a historical diagnosis of type 2 diabetes mellitus (T2DM) for at least 6 months prior to the screening visit (V1).
  2. Is male or female and aged from 18 to 75 years, inclusively.
  3. Has a body mass index (BMI) between 20 and 45 kg/m^2, inclusively.
  4. Is experiencing inadequate glycemic control with a glycosylated hemoglobin (HbA1c) concentration between 7.0% and 10.0%, inclusively.
  5. 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.
  6. Keeps constant body weight with fluctuation range no more than 10% over for at least 3 months before screening.
  7. 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.
  8. 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.
  9. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
  10. 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.

Exclusion Criteria:

  1. Type 1 diabetes mellitus.
  2. 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.
  3. 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.
  4. 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.
  5. Has an active proliferative retinopathy or macular degeneration that need to have an urgent treatment in the opinion of investigators.
  6. Has a frequent attack of hypoglycemia or loses consciousness due to hypoglycemia in the opinion of investigators.
  7. Has one or more times ketoacidosis or hyperosmotic status/coma.
  8. 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.
  9. Has a hematopathy (e.g. hemolytic anemia, drepanocytosis) that may interfere with the HbA1c test.
  10. Has other liabilities (e.g. drug abuse, alcoholism or mental disorder) that may hinder the participant to follow and complete the study.
  11. Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization.
  12. Is unsuitable for this study in the opinion of investigators.
  13. Has a disease need to use other taboo or caution drugs that is not listed in this study.
  14. If female, is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049814

Contacts
Contact: Takeda Study Registration Call Center 800-778-2860 medicalinformation@tpna.com

Locations
China, Anhui
Recruiting
Maanshan, Anhui, China
China, Beijing
Recruiting
Beijing, Beijing, China
China, Jilin
Recruiting
Changchun, Jilin, China
China, Shanxi
Recruiting
Yanan, Shanxi, China
China, Tianjin
Recruiting
Tianjin, Tianjin, China
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director, Clinical Science Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02049814     History of Changes
Other Study ID Numbers: BASCN1201, U1111-1147-3393, VOG-P4-001
Study First Received: January 28, 2014
Last Updated: July 18, 2014
Health Authority: China: Ethics Committee

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Voglibose
Metformin
Acarbose
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014