Diabetes Mellitus Type 2 Without ComplicationPhase 3VMGMProtocolNCT05688332
Glycaemic & Cardiovascular Treatment Outcomes of Voglibose Vs Glibenclamide Added to Metformin in T2DM Patients
A Phase 3 study testing Voglibose + Metformin and Glibenclamide + Metformin in people with Diabetes Mellitus Type 2 Without Complication, run by University of Zambia.
Trial summary
The goal of this clinical trial is to compare blood-sugar control and blood circulatory system risk-position in type 2 diabetes patients on voglibose versus those on glybenclamide when the two drugs are added to metformin because metformin alone is not controlling the blood-sugar well. Read more about this study
- Who is it for?
- Ages 22 to 59 years
- Conditions the study is for
- Diabetes Mellitus Type 2 Without Complication
- What is being tested?
- Voglibose + Metformin and Glibenclamide + Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 22 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study1 procedures and availability for the durtion of the study.
- Male or female, aged 22-59 years.
- In good general health as evidenced by medical history, diagnosed with T2DM and on tolerated dose of at least 2g/day of metformin monotherapy.
- Ability to take oral medication and be willing to adhere to the medication regimen through out the study period.
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- For females of reproductive potential use of highly effective contraception.
- Native-Zambian participants
- Must be on metformin monotherapy for 12 weeks or longer.
- Glycated haemoglobin (HbA1c) must be >7.0% within 12 weeks before screening.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Hypersensitivity or contraindication to AGIs
- Hypersensitivity or contraindication to SUs
- Type 2 diabetes patients with pregnancy or lactation
- Patients with acute complications like diabetic ketoacidosis, or hyperosmolar hyperglycaemic state at the time of screening
- Patients with established cardiovascular disease, e.g.; HF, coronary artery disease
- Patients with altered haemoglobin levels, e.g.; in conditions like anaemias and haemoglobimopathies such as thalassemia
- Patients on concomitant corticosteroid therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Glycaemic and Cardiovascular Treatment Outcomes of Voglibose Versus Glibenclamide Added to Metformin in T2DM Patients in Zambia: An Open-label Randomised Clinical Trial
The goal of this clinical trial is to compare blood-sugar control and blood circulatory system risk-position in type 2 diabetes patients on voglibose versus those on glybenclamide when the two drugs are added to metformin because metformin alone is not controlling the blood-sugar well. The results of this trial will help in improving the health and treatment results of the type 2 diabetic patients.
The main question the trial aims to answer is whether there is a difference in blood-sugar and blood circulatory system treatment results between voglibose + metformin and glibenclamide + metformin treatment combinations.
Read more
Participants that agree to participate in the trial will be asked to provide a sample of blood so that the following measurable laboratory factors will be used to compare any differences in treatment results between the two treatment groups from the beginning to the end of the trial:
- Total Cholesterol (TC),
- Low Density Lipoproteins (LDL-c),
- High Density Lipoproteins (HDL-c),
- Fasting Triglycerides (FTG),
- Fasting blood sugar (FBS),
- Post prandial blood sugar (PPBG),
- Glycated hemoglobin (HbA1c) correlated to hemoglobin level,
- creatinine,
- blood urea and
- electrolytes (K+, Na+, Cl-).
Read the detailed description
BACKGROUND: Diabetes is an increasingly important risk factor for CVD. Individuals with it continually have an increased risk of CV caused mortality. It can be classified as T1DM, T2DM, GDM and others. Metformin is a T2DM 1st line Oral Hypoglycaemic Agent (OHA). It usually requires a 2nd line add-on drug if blood glucose control is not on target. The add-on drug can either be insulin, an injectable incretin mimetic, or an OHA. The choice of the OHA should be considered with regard to improving the glycaemic control as well as reducing the CVD risk. Glibenclamide, a Sulphonylurea (SU), is a commonly used OHA in Zambia. It is associated with hypoglycaemia and arrhythmias. On the other hand voglibose, an alpha glucosidase inhibitor (AGI), is not associated with hypoglycaemia or with negative CV events. AGIs are associated with reduced PPBG by reducing the absorption of glucose in the GI tract after a carbohydrate meal. Reduced PPBG prevents macrovascular complications. Since maize (a carbohydrate) is a staple food in Zambia, there is need to investigate the glycaemic control in patients with T2DM using voglibose which is as affordable as glibenclamide.
MAIN AIM: To investigate the extent of glycaemic control and CV risk parameter effects of voglibose versus glibenclamide add-on therapies in Zambian patients with T2DM as we do not have published studies on these parameters in our patients.
METHOD: This study will be a 12 weeks dual-center open-label randomised clinical trial to comparatively evaluate the glycaemic and CV treatment outcomes of voglibose vs glibenclamide add-on therapies in native Zambian patients with T2DM inadequately controlled on 1g/day of metformin monotherapy. In this study, glycaemic and CV parameters will be quantified and classified in the laboratory to determine extent of glycaemic control and CVD risk reduction. Participants to be included will be male and female native Zambian patients aged 22 to 59 years on metformin monotherapy for at least 12 weeks with HbA1c > 7.0%. They will be randomly allocated by study team members to two treatment arms i.e., the voglibose-metformin or the glibenclamide-metformin regimen in a 1:1 computer generated simple randomisation. The participants will then be followed up to the 6th and 12th week for data collection prior to comparative analysis of the expected outcome.
EXPECTED OUTCOME: Change in glycaemic and CV parameters in the two groups after 6 and 12 weeks of add-on therapy.
SIGNIFICANCE: To help determine the glycaemic and CV risk status of patients with T2DM on voglibose and glibenclamide, thereby ascertain improvement in their healthcare and treatment outcomes.
- Being tested
- Voglibose + Metformin, Glibenclamide + Metformin
- Keywords
- voglibose, Metformin, Glibenclamide, Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voglibose + MetforminDrug
In treatment group B, 59 participants will also be randomly assigned to the voglibose 0.2/0.3mg TDS + metformin 500mg BD treatment combination to be taken orally daily, during or immediately after meals with dose titration at day 6 and 12 if the average fasting blood glucose (FBG) level is ≥7 mmol/L (126 mg/dL) and then dosage will be maintained for the remainder of the treatment period Participants in the intervention group initially receiving voglibose 0.2mg + metformin 500mg BD will be dose-titrated to voglibose 0.3mg +metformin 1g BD.
The duration of therapy for each participant will be 12 weeks, which is the minimum period for evaluating the primary endpoint.
Glibenclamide + MetforminDrug
The drugs (glibenclamide + metformin), in the control or comparator group will also be taken orally, glibenclamide once a day (OD) before meals, and metformin twice a day (BD) also before meals. These drugs will also be taken with a dose-titration at days 6 and 12 if the average is FBG level will be ≥ 7 mmol/L and the dose will be maintained for the remainder of the study period.
The duration of therapy for each participant will be 12 weeks, which is the minimum period for evaluating the primary endpoint. In this group, participants will initially receive glibenclamide 5mg once daily (OD) + metformin 500mg BD then will be dose-titrated to glibenclamide 10mg OD + metformin 1g BD.
| Study group | Role | What they receive |
|---|---|---|
| Voglibose + Metformin (Group B) | Experimental | In the B treatment group, 59 participants will be randomly assigned to initially voglibose 0.2mg TDS immediately before meals + metformin 500mg BD immediately before meals daily. Individual drug doses will be adjusted to the next higher doses after 6 to 12 days, at next clinical visits based on home based recorded blood glucose profiles. The maximum daily recommended dose of metformin of 2g and voglibose 0.9mg will not be exceeded. Receives: Drug: Voglibose + Metformin |
| Glibenclamide + Metformin (Group A) | Active comparator | In treatment group A, 59 participants will initially be randomly allocated by study team members to the glibenclamide 5mg O.D + metformin 500mg BD regimen.
In this study, 10mg glibenclamide and 2g metformin will not be exceeded daily. Receives: Drug: Glibenclamide + Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean Glycated Hemoglobin (HbA1c) levels
The null hypothesis is that there is no significant difference between the voglibose and glibenclamide treatment groups in the change in mean HbA1c levels after 6 weeks of add-on therapy to metformin in the T2DM patients (i.e. H0: µ1 = µ2 where µ1 is the mean HbA1c change in the glibenclamide group and µ2 is the mean HbA1c change in the voglibose group). The alternative hypothesis is that there is a significant difference between the voglibose and glibenclamide groups in the change in mean HbA1c levels after 6 weeks of add-on therapy to metformin in the T2DM patients (i.e. H1: µ1 ≠ µ2).
Measured: Baseline & Week 6
Change in mean Glycated Hemoglobin (HbA1c) levels
The null hypothesis is that there is no significant difference between the voglibose and glibenclamide treatment groups in the change in mean HbA1c levels after 12 weeks of add-on therapy to metformin in the T2DM patients (i.e. H0: µ1 = µ2 where µ1 is the mean HbA1c change in the glibenclamide group and µ2 is the mean HbA1c change in the voglibose group). The alternative hypothesis is that there is a significant difference between the voglibose and glibenclamide groups in the change in mean HbA1c levels after 12 weeks of add-on therapy to metformin in the T2DM patients (i.e. H1: µ1 ≠ µ2).
Measured: Baseline & Week 12
Secondary outcomes (12)
Change in Glycemic control with regard to Fasting Plasma Glucose (FPG)
Differences in change in glycemic control with regard to FPG: The null hypothesis is that there is no significant difference between the voglibose and glibenclamide treatment groups in the mean FPG change (i.e. H0: µ1 = µ2 where µ1 and µ2 represent the mean FPG change in the glibenclamide and voglibose groups respectively). The alternative hypothesis is that there is a difference between the voglibose and glibenclamide groups in the mean changes of FPG (i.e. H1: µ1 ≠ µ2).
Measured: Baseline & week 6
Change in glycemic control with regard to Fasting Plasma Glucose (FPG)
Differences in change in glycemic control with regard to FPG: The null hypothesis is that there is no significant difference between the voglibose and glibenclamide treatment groups in the mean FPG change (i.e. H0: µ1 = µ2 where µ1 and µ2 represent the mean FPG change in the glibenclamide and voglibose groups respectively). The alternative hypothesis is that there is a difference between the voglibose and glibenclamide groups in the mean changes of FPG (i.e. H1: µ1 ≠ µ2).
Measured: Baseline & week 12
Change in glycemic control with regard to Post Prandial Blood Glucose (PPBG)
Differences in Change in glycemic control with regard to PPBG: The null hypothesis is that there is no significant difference between the voglibose and glibenclamide treatment groups in the mean PPBG change (i.e. H0: µ1 = µ2 where µ1 and µ2 represent the mean PPBG change in the glibenclamide and voglibose groups respectively). The alternative hypothesis is that there is a difference between the voglibose and glibenclamide groups in the mean changes of PPBG (i.e. H1: µ1 ≠ µ2).
Measured: Baseline & week 6
Change in glycemic control with regard to Post Prandial Blood Glucose (PPBG)
Differences in change in glycemic control with regard to PPBG: The null hypothesis is that there is no significant difference between the voglibose and glibenclamide treatment groups in the mean PPBG change (i.e. H0: µ1 = µ2 where µ1 and µ2 represent the mean PPBG change in the glibenclamide and voglibose groups respectively). The alternative hypothesis is that there is a difference between the voglibose and glibenclamide groups in the mean changes of PPBG (i.e. H1: µ1 ≠ µ2).
Measured: Baseline & week 12
Lipid profile (LDL-c, HDL-c, TC, TG) comparison
Lipid profile (LDL-c, HDL-c, TC, TG) comparison: The null hypothesis is that there is no difference between the voglibose and glibenclamide groups in the mean changes in lipid profile (i.e. H0: µ1 = µ2 where µ1 and µ2 represent the mean changes in lipid profile in the glibenclamide and voglibose groups respectively). The alternative hypothesis is that there is a difference between voglibose and glibenclamide groups in the mean changes in lipid profile (i.e. H1: µ1 ≠ µ2).
Measured: Baseline & Week 6
Lipid profile (LDL-c, HDL-c, TC, TG) comparison
Lipid profile (LDL-c, HDL-c, TC, TG) comparison: The null hypothesis is that there is no difference between the voglibose and glibenclamide groups in the mean changes in lipid profile (i.e. H0: µ1 = µ2 where µ1 and µ2 represent the mean changes in lipid profile in the glibenclamide and voglibose groups respectively). The alternative hypothesis is that there is a difference between voglibose and glibenclamide groups in the mean changes in lipid profile (i.e. H1: µ1 ≠ µ2).
Measured: Baseline & Week 12
Anthropometric parameter changes in BMI
Anthropometric parameter changes in BMI: The null hypothesis is that there is no difference between the voglibose and glibenclamide groups in the mean anthropometric parameter changes (i.e. H0: µ1 = µ2 where µ1 and µ2 represent the mean anthropometric parameter changes in the glibenclamide and voglibose groups respectively). The alternative hypothesis is that there is a difference between voglibose and glibenclamide groups in the mean anthropometric parameter changes (i.e. H1: µ1 ≠ µ2).
Measured: Baseline & Week 6
Anthropometric parameter changes in BMI
Anthropometric parameter changes in BMI: The null hypothesis is that there is no difference between the voglibose and glibenclamide groups in the mean anthropometric parameter changes (i.e. H0: µ1 = µ2 where µ1 and µ2 represent the mean anthropometric parameter changes in the glibenclamide and voglibose groups respectively). The alternative hypothesis is that there is a difference between voglibose and glibenclamide groups in the mean anthropometric parameter changes (i.e. H1: µ1 ≠ µ2).
Measured: Baseline & Week 12
Anthropometric parameter changes in Waist Circumference (WC)
Anthropometric parameter changes in WC: The null hypothesis is that there is no difference between the voglibose and glibenclamide groups in the mean anthropometric parameter changes (i.e. H0: µ1 = µ2 where µ1 and µ2 represent the mean anthropometric parameter changes in the glibenclamide and voglibose groups respectively). The alternative hypothesis is that there is a difference between voglibose and glibenclamide groups in the mean anthropometric parameter changes (i.e. H1: µ1 ≠ µ2).
Measured: Baseline & Week 6
Anthropometric parameter changes in Waist Circumference (WC)
Anthropometric parameter changes in WC: The null hypothesis is that there is no difference between the voglibose and glibenclamide groups in the mean anthropometric parameter changes (i.e. H0: µ1 = µ2 where µ1 and µ2 represent the mean anthropometric parameter changes in the glibenclamide and voglibose groups respectively). The alternative hypothesis is that there is a difference between voglibose and glibenclamide groups in the mean anthropometric parameter changes (i.e. H1: µ1 ≠ µ2).
Measured: Baseline & Week 12
Drug related AEs
Drug related AEs: The null hypothesis is that there is no difference between the proportion of participants experiencing drug related AEs in the voglibose and glibenclamide groups (i.e. H0: p1 = p2 where p1 and p2 represent the proportion of participants experiencing a drug related AE in the glibenclamide and voglibose groups, respectively). The alternative hypothesis is that there is a difference between the proportion of participants experiencing drug related AEs in the voglibose and glibenclamide groups (i.e. H1: p1 ≠ p2).
Measured: Baseline & Week 6
Drug related AEs
Drug related AEs: The null hypothesis is that there is no difference between the proportion of participants experiencing drug related AEs in the voglibose and glibenclamide groups (i.e. H0: p1 = p2 where p1 and p2 represent the proportion of participants experiencing a drug related AE in the glibenclamide and voglibose groups, respectively). The alternative hypothesis is that there is a difference between the proportion of participants experiencing drug related AEs in the voglibose and glibenclamide groups (i.e. H1: p1 ≠ p2).
Measured: Baseline & Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study startAug 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2 Without ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- University Teaching Hospital, Lusaka, Zambia
- Responsible party
- Principal investigator, Lawrence Mukela, University of Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688332
- Sponsor's protocol ID
- 202112030076
- Other IDs
- IRB Number: 00011000, IORG Number: 0009227, FWA Number: 00026270
- Acronym
- VMGMProtocol
- Status last verified
- Jun 2023
- First submitted
- 27 Dec 2022
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in diabetes mellitus. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting parties.
Publications
American Diabetes Association Professional Practice Committee. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022 Jan 1;45(Suppl 1):S17-S38. doi: 10.2337/dc22-S002.
PubMed 34964875Rosenquist KJ, Fox CS. Mortality Trends in Type 2 Diabetes. In: Cowie CC, Casagrande SS, Menke A, Cissell MA, Eberhardt MS, Meigs JB, Gregg EW, Knowler WC, Barrett-Connor E, Becker DJ, Brancati FL, Boyko EJ, Herman WH, Howard BV, Narayan KMV, Rewers M, Fradkin JE, editors. Diabetes in America. 3rd edition. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases (US); 2018 Aug. CHAPTER 36. Available from http://www.ncbi.nlm.nih.gov/books/NBK568010/
PubMed 33651566Coleman RL, Scott CAB, Lang Z, Bethel MA, Tuomilehto J, Holman RR. Meta-analysis of the impact of alpha-glucosidase inhibitors on incident diabetes and cardiovascular outcomes. Cardiovasc Diabetol. 2019 Oct 17;18(1):135. doi: 10.1186/s12933-019-0933-y.
PubMed 31623625Akmal M, Patel P, Wadhwa R. Alpha Glucosidase Inhibitors. 2024 Feb 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557848/
PubMed 32496728
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glycaemic and Cardiovascular Treatment Outcomes of Voglibose Versus Glibenclamide Added to Metformin in T2DM Patients in Zambia: An Open-label Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05688332
- Acronym / sponsor ID
- VMGMProtocol / 202112030076
- Keywords
- voglibose, Metformin, Glibenclamide, Outcomes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University of ZambiaUniversity, hospital or other
- Collaborators
- University Teaching Hospital, Lusaka, Zambia
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare blood-sugar control and blood circulatory system risk-position in type 2 diabetes patients on voglibose versus those on glybenclamide when the two drugs are added to metformin because metformin alone is not controlling the blood-sugar well. The results of this trial will help in improving the health and treatment results of the type 2 diabetic patients.
The main question the trial aims to answer is whether there is a difference in blood-sugar and blood circulatory system treatment results between voglibose + metformin and glibenclamide + metformin treatment combinations.
Participants that agree to participate in the trial will be asked to provide a sample of blood so that the following measurable laboratory factors will be used to compare any differences in treatment results between the two treatment groups from the beginning to the end of the trial:
- Total Cholesterol (TC),
- Low Density Lipoproteins (LDL-c),
- High Density Lipoproteins (HDL-c),
- Fasting Triglycerides (FTG),
- Fasting blood sugar (FBS),
- Post prandial blood sugar (PPBG),
- Glycated hemoglobin (HbA1c) correlated to hemoglobin level,
- creatinine,
- blood urea and
- electrolytes (K+, Na+, Cl-).
Detailed description
BACKGROUND: Diabetes is an increasingly important risk factor for CVD. Individuals with it continually have an increased risk of CV caused mortality. It can be classified as T1DM, T2DM, GDM and others. Metformin is a T2DM 1st line Oral Hypoglycaemic Agent (OHA). It usually requires a 2nd line add-on drug if blood glucose control is not on target. The add-on drug can either be insulin, an injectable incretin mimetic, or an OHA. The choice of the OHA should be considered with regard to improving the glycaemic control as well as reducing the CVD risk. Glibenclamide, a Sulphonylurea (SU), is a commonly used OHA in Zambia. It is associated with hypoglycaemia and arrhythmias. On the other hand voglibose, an alpha glucosidase inhibitor (AGI), is not associated with hypoglycaemia or with negative CV events. AGIs are associated with reduced PPBG by reducing the absorption of glucose in the GI tract after a carbohydrate meal. Reduced PPBG prevents macrovascular complications. Since maize (a carbohydrate) is a staple food in Zambia, there is need to investigate the glycaemic control in patients with T2DM using voglibose which is as affordable as glibenclamide.
MAIN AIM: To investigate the extent of glycaemic control and CV risk parameter effects of voglibose versus glibenclamide add-on therapies in Zambian patients with T2DM as we do not have published studies on these parameters in our patients.
METHOD: This study will be a 12 weeks dual-center open-label randomised clinical trial to comparatively evaluate the glycaemic and CV treatment outcomes of voglibose vs glibenclamide add-on therapies in native Zambian patients with T2DM inadequately controlled on 1g/day of metformin monotherapy. In this study, glycaemic and CV parameters will be quantified and classified in the laboratory to determine extent of glycaemic control and CVD risk reduction. Participants to be included will be male and female native Zambian patients aged 22 to 59 years on metformin monotherapy for at least 12 weeks with HbA1c > 7.0%. They will be randomly allocated by study team members to two treatment arms i.e., the voglibose-metformin or the glibenclamide-metformin regimen in a 1:1 computer generated simple randomisation. The participants will then be followed up to the 6th and 12th week for data collection prior to comparative analysis of the expected outcome.
EXPECTED OUTCOME: Change in glycaemic and CV parameters in the two groups after 6 and 12 weeks of add-on therapy.
SIGNIFICANCE: To help determine the glycaemic and CV risk status of patients with T2DM on voglibose and glibenclamide, thereby ascertain improvement in their healthcare and treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Voglibose + Metformin (Group B) | Experimental | Drug: Voglibose + MetforminIn the B treatment group, 59 participants will be randomly assigned to initially voglibose 0.2mg TDS immediately before meals + metformin 500mg BD immediately before meals daily. Individual drug doses will be adjusted to the next higher doses after 6 to 12 days, at next clinical visits based on home based recorded blood glucose profiles. The maximum daily recommended dose of metformin of 2g and voglibose 0.9mg will not be exceeded. |
| Glibenclamide + Metformin (Group A) | Active comparator | Drug: Glibenclamide + MetforminIn treatment group A, 59 participants will initially be randomly allocated by study team members to the glibenclamide 5mg O.D + metformin 500mg BD regimen. In this study, 10mg glibenclamide and 2g metformin will not be exceeded daily. |
Who may qualify
- Ages
- 22 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Key exclusion criteria (8 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voglibose + MetforminIn treatment group B, 59 participants will also be randomly assigned to the voglibose 0.2/0.3mg TDS + metformin 500mg BD treatment combination to be taken orally daily, during or immediately after meals with dose titration at day 6 and 12 if the average fasting blood glucose (FBG) level is ≥7 mmol/L (126 mg/dL) and then dosage will be maintained for the remainder of the treatment period Participants in the intervention group initially receiving voglibose 0.2mg + metformin 500mg BD will be dose-titrated to voglibose 0.3mg +metformin 1g BD. The duration of therapy for each participant will be 12 weeks, which is the minimum period for evaluating the primary endpoint. | Drug | Voglibose + Metformin (Group B) |
| Glibenclamide + MetforminThe drugs (glibenclamide + metformin), in the control or comparator group will also be taken orally, glibenclamide once a day (OD) before meals, and metformin twice a day (BD) also before meals. These drugs will also be taken with a dose-titration at days 6 and 12 if the average is FBG level will be ≥ 7 mmol/L and the dose will be maintained for the remainder of the study period. The duration of therapy for each participant will be 12 weeks, which is the minimum period for evaluating the primary endpoint. In this group, participants will initially receive glibenclamide 5mg once daily (OD) + metformin 500mg BD then will be dose-titrated to glibenclamide 10mg OD + metformin 1g BD. | Drug | Glibenclamide + Metformin (Group A) |
Primary outcome
Change in mean Glycated Hemoglobin (HbA1c) levels
Time frame: Baseline & Week 6
The null hypothesis is that there is no significant difference between the voglibose and glibenclamide treatment groups in the change in mean HbA1c levels after 6 weeks of add-on therapy to metformin in the T2DM patients (i.e. H0: µ1 = µ2 where µ1 is the mean HbA1c change in the glibenclamide group and µ2 is the mean HbA1c change in the voglibose group). The alternative hypothesis is that there is a significant difference between the voglibose and glibenclamide groups in the change in mean HbA1c levels after 6 weeks of add-on therapy to metformin in the T2DM patients (i.e. H1: µ1 ≠ µ2).
Change in mean Glycated Hemoglobin (HbA1c) levels
Time frame: Baseline & Week 12
The null hypothesis is that there is no significant difference between the voglibose and glibenclamide treatment groups in the change in mean HbA1c levels after 12 weeks of add-on therapy to metformin in the T2DM patients (i.e. H0: µ1 = µ2 where µ1 is the mean HbA1c change in the glibenclamide group and µ2 is the mean HbA1c change in the voglibose group). The alternative hypothesis is that there is a significant difference between the voglibose and glibenclamide groups in the change in mean HbA1c levels after 12 weeks of add-on therapy to metformin in the T2DM patients (i.e. H1: µ1 ≠ µ2).
12 secondary outcomes
Change in Glycemic control with regard to Fasting Plasma Glucose (FPG)
Time frame: Baseline & week 6
Change in glycemic control with regard to Fasting Plasma Glucose (FPG)
Time frame: Baseline & week 12
Change in glycemic control with regard to Post Prandial Blood Glucose (PPBG)
Time frame: Baseline & week 6
Change in glycemic control with regard to Post Prandial Blood Glucose (PPBG)
Time frame: Baseline & week 12
Lipid profile (LDL-c, HDL-c, TC, TG) comparison
Time frame: Baseline & Week 6
Lipid profile (LDL-c, HDL-c, TC, TG) comparison
Time frame: Baseline & Week 12
Anthropometric parameter changes in BMI
Time frame: Baseline & Week 6
Anthropometric parameter changes in BMI
Time frame: Baseline & Week 12
Anthropometric parameter changes in Waist Circumference (WC)
Time frame: Baseline & Week 6
Anthropometric parameter changes in Waist Circumference (WC)
Time frame: Baseline & Week 12
Drug related AEs
Time frame: Baseline & Week 6
Drug related AEs
Time frame: Baseline & Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Background: PubMed 34964875American Diabetes Association Professional Practice Committee. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022 Jan 1;45(Suppl 1):S17-S38. doi: 10.2337/dc22-S002.
- Background: PubMed 33651566Rosenquist KJ, Fox CS. Mortality Trends in Type 2 Diabetes. In: Cowie CC, Casagrande SS, Menke A, Cissell MA, Eberhardt MS, Meigs JB, Gregg EW, Knowler WC, Barrett-Connor E, Becker DJ, Brancati FL, Boyko EJ, Herman WH, Howard BV, Narayan KMV, Rewers M, Fradkin JE, editors. Diabetes in America. 3rd edition. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases (US); 2018 Aug. CHAPTER 36. Available from http://www.ncbi.nlm.nih.gov/books/NBK568010/
- Background: PubMed 31623625Coleman RL, Scott CAB, Lang Z, Bethel MA, Tuomilehto J, Holman RR. Meta-analysis of the impact of alpha-glucosidase inhibitors on incident diabetes and cardiovascular outcomes. Cardiovasc Diabetol. 2019 Oct 17;18(1):135. doi: 10.1186/s12933-019-0933-y.
- Background: PubMed 32496728Akmal M, Patel P, Wadhwa R. Alpha Glucosidase Inhibitors. 2024 Feb 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557848/
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in diabetes mellitus. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Voglibose + Metformin and Glibenclamide + Metformin in people with Diabetes Mellitus Type 2 Without Complication, run by University of Zambia.
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 8 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brown Kamanga, MMed (+260 97 2758137, brownkamanga@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean Glycated Hemoglobin (HbA1c) levels (time frame: Baseline & Week 6). The study lists 2 primary outcomes in all. 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 NCT05688332, which also lists 4 linked publications.
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 3 Jul 2023.