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Type 2 Diabetes MellitusPhase 4NCT02049814

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

A Phase 4 study testing Metformin, Voglibose and Acarbose in people with Type 2 Diabetes Mellitus, run by Takeda at 18 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Metformin, Voglibose and Acarbose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
494 participants
Where
18 sitesChina
Study dates
9 May 2014to 28 Jun 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • Study site

    Beijing, Beijing Municipality

  • Study site

    Changchun, Jilin

  • Study site

    Guangzhou, Guangdong

  • Study site

    Hefei, Anhui

  • Study site

    Jilin City, Jilin

  • Study site

    Maanshan, Anhui

  • Study site

    Nanjing, Jiangsu

  • Study site

    Qingdao, Shandong

  • Study site

    Shanghai, Shanghai Municipality

  • Study site

    Shenyang, Liaoning

  • Study site

    Shenzhen, Guangdong

  • Study site

    Taishan, Guangdong

  • Study site

    Tianjin, Tianjin Municipality

  • Study site

    Wenzhou, Zhejiang

  • Study site

    Xuzhou, Jiangsu

  • Study site

    Yan’an, Shanxi

  • Study site

    Yanan, Shanxi

  • Study site

    Zhuzhou, Hunan

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Metformin, Voglibose, Acarbose
Keywords
Drug therapy
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Also called Glucophage

    Metformin tablets

  • VogliboseDrug

    Also called Basen

    Voglibose tablets

  • AcarboseDrug

    Also called Glucobay, Precose, Prandase

    Acarbose tablets

Study groups in NCT02049814
Study groupRoleWhat they receive
Metformin + Voglibose 0.2 mgExperimentalMetformin 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.
Receives: Drug: Metformin; Drug: Voglibose
Metformin + Acarbose 50 mgActive comparatorMetformin 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.
Receives: Drug: Metformin; Drug: Acarbose

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 12

Secondary outcomes (10)

  1. Change From Baseline in HbA1c at 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.

    Measured: Baseline and Week 6

  2. Change From Baseline in Fasting Blood Glucose Over Time

    The change between the fasting blood glucose value collected at weeks 6 and 12 or final visit relative to baseline.

    Measured: Baseline, Weeks 6 and 12

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

    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.

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

  4. Change From Baseline in Fasting Insulin at Week 12

    The change between the fasting insulin value collected at week 12 or final visit relative to baseline.

    Measured: Baseline, Week 12

  5. Change From Baseline in Postprandial Serum Insulin at Week 12

    The change from Baseline in postprandial serum insulin, after 1 and 2 hours of meal collected at Week 12 relative to baseline.

    Measured: 1 and 2 hours after meal at Baseline and Week 12

  6. Change From Baseline in Fasting Glucagon at Week 12

    The change between the fasting glucagon value collected at week 12 or final visit relative to baseline.

    Measured: Baseline, Week 12

  7. Change From Baseline in Postprandial Serum Glucagon at Week 12

    The change from Baseline in postprandial serum glucagon, after 1 and 2 hours of meal collected at Week 12 relative to baseline.

    Measured: 1 and 2 hours after meal at Baseline and Week 12

  8. Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) at 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.

    Measured: Baseline, Week 12

  9. Change From Baseline in Insulin Homeostatic Model Assessment Beta Cell Function (HOMA β) at 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.

    Measured: Baseline, Week 12

  10. Change From Baseline in Body Weight Over Time

    The change between body weight at weeks 2, 6 and 12 or relative to baseline.

    Measured: Baseline, Weeks 2, 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2014 (estimated)
  2. Study start9 May 2014
  3. Primary completion1 Jun 2016
  4. Study completion28 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
494 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02049814
Sponsor's protocol ID
BASCN1201
Other IDs
U1111-1147-3393, VOG-P4-001
Status last verified
Feb 2019
First submitted
28 Jan 2014
Last updated
13 Mar 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin, Voglibose and Acarbose in people with Type 2 Diabetes Mellitus, run by Takeda at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02049814.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.

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