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

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ClinicalTrials.gov Identifier: NCT02049814
Recruitment Status : Completed
First Posted : January 30, 2014
Results First Posted : February 4, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Metformin Drug: Voglibose Drug: Acarbose Phase 4

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 494 patients. All participants will be enrolled in a 2-week screening phase and a metformin run-in phase. Eligible participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:

  • Metformin and Voglibose 0.2 mg
  • Metformin and Acarbose 50 mg

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-center 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 494 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Non-inferiority Study to Compare the Efficacy and Safety of Voglibose and Acarbose in Patients With Type 2 Diabetes Mellitus With Poor Control of Metformin
Actual Study Start Date : May 9, 2014
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : June 28, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metformin + Voglibose 0.2 mg
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 50 mg
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




Primary Outcome Measures :
  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 [ Time Frame: Baseline, 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.


Secondary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 6 [ Time Frame: Baseline and Week 6 ]
    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 6 relative to baseline.

  2. Change From Baseline in Fasting Blood Glucose Over Time [ Time Frame: Baseline, Weeks 6 and 12 ]
    The change between the fasting blood glucose value collected at weeks 6 and 12 or final visit relative to baseline.

  3. Change From Baseline in Postprandial Plasma Glucose (PPG) Over Time [ Time Frame: 1 and 2 hours after meal at Baseline, Weeks 6 and 12 ]
    The change between the value of glucose after 1 and 2 hours of meal, measured by the meal tolerance test collected at Weeks 6 and 12 or relative to baseline.

  4. Change From Baseline in Fasting Insulin at Week 12 [ Time Frame: Baseline, Week 12 ]
    The change between the fasting insulin value collected at week 12 or final visit relative to baseline.

  5. Change From Baseline in Postprandial Serum Insulin at Week 12 [ Time Frame: 1 and 2 hours after meal at Baseline and Week 12 ]
    The change from Baseline in postprandial serum insulin, after 1 and 2 hours of meal collected at Week 12 relative to baseline.

  6. Change From Baseline in Fasting Glucagon at Week 12 [ Time Frame: Baseline, Week 12 ]
    The change between the fasting glucagon value collected at week 12 or final visit relative to baseline.

  7. Change From Baseline in Postprandial Serum Glucagon at Week 12 [ Time Frame: 1 and 2 hours after meal at Baseline and Week 12 ]
    The change from Baseline in postprandial serum glucagon, after 1 and 2 hours of meal collected at Week 12 relative to baseline.

  8. Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) at Week 12 [ Time Frame: Baseline, Week 12 ]
    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.

  9. Change From Baseline in Insulin Homeostatic Model Assessment Beta Cell Function (HOMA β) at Week 12 [ Time Frame: Baseline, Week 12 ]
    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.

  10. Change From Baseline in Body Weight Over Time [ Time Frame: Baseline, Weeks 2, 6 and 12 ]
    The change between body weight at weeks 2, 6 and 12 or relative to baseline.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049814


Locations
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China, Anhui
Hefei, Anhui, China
Maanshan, Anhui, China
China, Beijing
Beijing, Beijing, China
China, Guangdong
Guangzhou, Guangdong, China
Shenzhen, Guangdong, China
Taishan, Guangdong, China
China, Hunan
Zhuzhou, Hunan, China
China, Jiangsu
Nanjing, Jiangsu, China
Xuzhou, Jiangsu, China
China, Jilin
Changchun, Jilin, China
Jilin, Jilin, China
China, Liaoning
Shenyang, Liaoning, China
China, Shandong
Qingdao, Shandong, China
China, Shanghai
Shanghai, Shanghai, China
China, Shanxi
Yan An, Shanxi, China
Yanan, Shanxi, China
China, Tianjin
Tianjin, Tianjin, China
China, Zhejiang
Wenzhou, Zhejiang, China
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director, Clinical Science Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02049814     History of Changes
Other Study ID Numbers: BASCN1201
U1111-1147-3393 ( Other Identifier: World Health Organization )
VOG-P4-001 ( Other Identifier: Takeda ID )
First Posted: January 30, 2014    Key Record Dates
Results First Posted: February 4, 2019
Last Update Posted: March 13, 2019
Last Verified: February 2019

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Acarbose
Voglibose
Inositol
Hypoglycemic Agents
Physiological Effects of Drugs
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances