TYpe 2 Diabetes MellitusPhase 4NCT02853630
A Clinical Trial to Study the Effects of Two Drugs, Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Metformin and Vildagliptin in people with TYpe 2 Diabetes Mellitus, run by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals at 6 sites in India.
Trial summary
This study is a multicentre, randomized, open label on comparison of pancreatic beta cell recovery and preservation of Vildagliptin 100mg daily and Metformin (1000 - 2500mg) daily for 96 weeks in 203 patients with type 2 diabetes that will be conducted in four centers in Chennai. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- TYpe 2 Diabetes Mellitus
- What is being tested?
- Metformin and Vildagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 6 sitesIndia
- Study dates
- Dec 2013to Dec 2018
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Newly Diagnosed Type 2 Diabetes Mellitus patients not receiving any medication for diabetes
- HbA1c ranging from 7.0% to ≤ 8.5%
- Body Mass Index (BMI) ≥ 19.0 to ≤ 25.0 kg/m2
- Male and female subjects of age between 20 - 60 years shall be selected
- Adult subjects willing to give informed consent
- Subject must be available for and willing to attend all evaluation visits
- Willingness to follow the protocol requirements as evidenced by written informed consent
- Subject must have access to telephone for calling into the clinical center as part of test product compliance
Who cannot join
- Type 1 diabetes
- BMI ≤18.99 kg/m2 or> 25 kg/m2
- Presence of severe vascular complications
- Indications for use of insulin
- Elevated serum levels of lipase and amylase (>1.5 ULN)
- Gamma-glutamyltransferase >2 times upper limit of normal (ULN) at Visit1, confirmed by repeated measure within 3 working days
Show all 22Show fewer
- Urine albumin: creatinine ratio (UACR) >1800 mg/g (>203.4 mg/mmol)
- Subjects below the age of 20 years and above the age of 60 years
- History of any drug abuse in the past 12 months
- History of hypersensitivity to study drugs and related drugs or excipients in the formulation.
- History of allergy to vegetables and or food substances and or any other manifestations suggestive of hypersensitivity reactions
- Subject who is not willing to participate in the study
- Clinically significant abnormal laboratory results at screening.
- Subject is being treated for severe active infection of any type
- A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study
- Subject with clinically relevant uncontrolled medical condition (e.g hematologic renal hepatic neurology cardiac or respiratory)
- Subject has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years
- Participating in a clinical research trial within 30 days prior to screening
- Donated blood 3 months prior to first study visit and during the study period
- Individuals who are cognitively impaired and or who are unable to give informed consent
- Known HIV or Hepatitis B or C positive
- Any other health or mental condition that in the Investigator's opinion may adversely affect the subjects ability to complete the study or its measures or that may pose significant risk to the subject
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Jnana Sanjeevini Medical Centre
Bangalore, Karnataka, 560 078
Singhvi Health Centre
Chennai, Tamil Nadu, 600 019
Dr V.Seshiah Diabetes research Institute, Dr V.Balaji Diabetes care centre
Chennai, Tamil Nadu, 600029
Arthur Asirvatham Hospital
Madurai, Tamil Nadu, 625 020
Vikas Pai Research Foundation
Pune, Maharashtra, 411 005
Ramana Maharishi Rangammal Hospital
Tiruvannamalai, Tamil Nadu, 606 603
About this study
Official title: A Multicentric, Randomized, Open Label Study on Comparison of Pancreatic Beta Cell Recovery and Preservation in Type 2 Diabetic Patients Treated With DPP-4 Inhibitor (Vildagliptin) and Metformin
This study is a multicentre, randomized, open label on comparison of pancreatic beta cell recovery and preservation of Vildagliptin 100mg daily and Metformin (1000 - 2500mg) daily for 96 weeks in 203 patients with type 2 diabetes that will be conducted in four centers in Chennai. The primary outcome measures will be to compare the effects of Vildagliptin versus Metformin on Pancreatic beta cell function in type 2 diabetic patients as measure by Insulin secretion rate (ISR) relative to glucose0-2hr (pmol/min/m2/mmol/L). The secondary outcomes will be effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of Percent HbA1c reduction, C-peptide responses, Insulin to glucose ratios, Reduction in fasting plasma glucose (FPG), 2hr postprandial glucose (PPG) from baseline, Improvement in insulin sensitivity, Improvement in oral disposition index, Percentage of patients reaching the glycemic target of (i) HbA1c ≤ 6.5% and (ii)HbA1c ≤ 7.0%, in the overall study population and General safety in terms of occurrence of adverse events
Read the detailed description
The subjects will be invited to the study center from the local population who are willing to participate in the trial. Each subject will be informed both orally and in writing about the study prior to inclusion in the study and only the subjects who give written informed consent will be included. The selection of the subjects is based on the inclusion and exclusion criteria defined in the protocol. The selected subjects will be given a screening number and subjected to screening procedure to find out eligible candidates for enrollment. The screening procedure includes obtaining subject's anthropometric data, baseline symptomatology, medical history, physical examination, laboratory investigations like blood glucose (fasting, 30min \& 2hr after meal), HbA1c, ^Plasma insulin (fasting, 30min \& 2hr after meal), ^2hr C peptide, Serum Amylase, Lipase, Urea, Creatinine, Gamma-glutamyl transferase (GGT), Urine albumin/creatinine ratio and urine pregnancy (if applicable).
The selected subjects after the screening procedure will be given a subject number and randomized between two arms. In Arm 1 they will be advised to take Vildagliptin 100mg daily for 96 weeks. In Arm 2 they are assigned Metformin (1000mg - 2500 mg/ day according to physician's preference for 96 weeks and all the subjects will be asked to come for follow up on week 12, week 24, week 48, week 72 and week 96. Subjects will be given sufficient quantity of study drugs. They will be instructed to take one tablet of Vildagliptin 50mg per day, 30 minutes after breakfast in the morning and second tablet at night, 30 minutes after dinner or Metformin tablets as per instructions given by the physician. Subjects will be instructed to maintain the record of dosing details in the patient diary.
Blood samples will be taken for the investigations such as blood glucose (fasting, 30min \& 2hr after meal), HbA1c, Plasma insulin (fasting, 30min \& 2hr after meal), C peptide (2hr after meal), fasting serum Amylase, Lipase, Urea, Creatinine, GGT, Urine albumin/creatinine ratio and Urine pregnancy test(if required) as specified in visit chart below. There will be three telephonic visits on week 36, week 60 and week 84. During those visits subject will be inquired about the health status over the phone and the drugs for the next three months will be dispensed by courier or delivered at home by the coordinator.
If the glycaemic control is constantly not satisfactory (HbA1c ≥ 8.5%) from visit 3, a rescue drug (Glimepiride) will be added to both arms and all the clinical and biochemical test will be done as per visit chart. With Glimepiride if the A1C is >9% insulin will be added and the subject will be withdrawn from the study.
- Conditions
- TYpe 2 Diabetes Mellitus
- Being tested
- Metformin, Vildagliptin
- 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
Participant will be instructed to take Metformin tablets as per instructions given by the physician.
VildagliptinDrug
Participant will be instructed to take one tablet of Vildagliptin 50mg per day, 30 minutes after breakfast in the morning and second tablet at night, 30 minutes after dinner
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Tablet Metformin 1000 - 2500 mg/day for 96 weeks Receives: Drug: Metformin |
| Vildagliptin | Experimental | Tablet Vildagliptin 100mg/day for 96 weeks Receives: Drug: Vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Insulin secretion rate
To compare the effects of Vildagliptin versus Metformin on Pancreatic beta cell function in type 2 diabetic subjects as measure by Insulin secretion rate (ISR) relative to glucose0-2hr (pmol/min/m2/mmol/L)
Measured: Baseline and 96 weeks
Secondary outcomes (10)
Changes in HbA1c reduction
Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of Percent HbA1c reduction
Measured: Baseline and 96 weeks
Changes in C peptide response
Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of C peptide response
Measured: Baseline and 96 weeks
Changes in Insulin to glucose ratio
Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of insulin to glucose ratio
Measured: Baseline and 96 weeks
Changes in Fasting plasma glucose
Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of reduction in fasting plasma glucose
Measured: Baseline and 96 weeks
Changes in 2hr postprandial plasma glucose
Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of reduction in 2hr postprandial plasma glucose
Measured: Baseline and 96 weeks
Changes in Insulin sensitivity
Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of improvement in insulin sensitivity
Measured: Baseline and 96 weeks
Changes in Oral disposition index
Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of improvement in oral disposition index
Measured: Baseline and 96 weeks
Percentage of subjects reaching HbA1c ≤ 6.5%
Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of percentage of subjects reaching the glycemic target of HbA1c ≤ 6.5%
Measured: Baseline and 96 weeks
Percentage of subjects reaching HbA1c ≤ 7.0%
Effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of percentage of subjects reaching the glycemic target of HbA1c ≤ 7.0%
Measured: Baseline and 96 weeks
Number of participant treated related to adverse event
Number of adverse event observed in both Vildagliptin and Metformin treatment group will be assessed
Measured: Baseline and 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startDec 2013
- Primary completionNov 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TYpe 2 Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ambady Ramachandran, MD,Ph.D,D.Sc, Principal investigator, President, India Diabetes Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853630
- Sponsor's protocol ID
- CLAF237AIN04
- Other IDs
- CTRI/2014/01/004301
- Status last verified
- Apr 2019
- First submitted
- 27 Jul 2016
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
PubMed 32501595
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Randomized, Open Label Study on Comparison of Pancreatic Beta Cell Recovery and Preservation in Type 2 Diabetic Patients Treated With DPP-4 Inhibitor (Vildagliptin) and Metformin
- ClinicalTrials.gov ID
- NCT02853630
- Acronym / sponsor ID
- CLAF237AIN04
- Conditions
- TYpe 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes HospitalsUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 3 Aug 2016 (estimated)
- 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.
This study is a multicentre, randomized, open label on comparison of pancreatic beta cell recovery and preservation of Vildagliptin 100mg daily and Metformin (1000 - 2500mg) daily for 96 weeks in 203 patients with type 2 diabetes that will be conducted in four centers in Chennai. The primary outcome measures will be to compare the effects of Vildagliptin versus Metformin on Pancreatic beta cell function in type 2 diabetic patients as measure by Insulin secretion rate (ISR) relative to glucose0-2hr (pmol/min/m2/mmol/L). The secondary outcomes will be effect of Vildagliptin versus Metformin based treatment on glycaemic variables in terms of Percent HbA1c reduction, C-peptide responses, Insulin to glucose ratios, Reduction in fasting plasma glucose (FPG), 2hr postprandial glucose (PPG) from baseline, Improvement in insulin sensitivity, Improvement in oral disposition index, Percentage of patients reaching the glycemic target of (i) HbA1c ≤ 6.5% and (ii)HbA1c ≤ 7.0%, in the overall study population and General safety in terms of occurrence of adverse events
Detailed description
The subjects will be invited to the study center from the local population who are willing to participate in the trial. Each subject will be informed both orally and in writing about the study prior to inclusion in the study and only the subjects who give written informed consent will be included. The selection of the subjects is based on the inclusion and exclusion criteria defined in the protocol. The selected subjects will be given a screening number and subjected to screening procedure to find out eligible candidates for enrollment. The screening procedure includes obtaining subject's anthropometric data, baseline symptomatology, medical history, physical examination, laboratory investigations like blood glucose (fasting, 30min \& 2hr after meal), HbA1c, ^Plasma insulin (fasting, 30min \& 2hr after meal), ^2hr C peptide, Serum Amylase, Lipase, Urea, Creatinine, Gamma-glutamyl transferase (GGT), Urine albumin/creatinine ratio and urine pregnancy (if applicable).
The selected subjects after the screening procedure will be given a subject number and randomized between two arms. In Arm 1 they will be advised to take Vildagliptin 100mg daily for 96 weeks. In Arm 2 they are assigned Metformin (1000mg - 2500 mg/ day according to physician's preference for 96 weeks and all the subjects will be asked to come for follow up on week 12, week 24, week 48, week 72 and week 96. Subjects will be given sufficient quantity of study drugs. They will be instructed to take one tablet of Vildagliptin 50mg per day, 30 minutes after breakfast in the morning and second tablet at night, 30 minutes after dinner or Metformin tablets as per instructions given by the physician. Subjects will be instructed to maintain the record of dosing details in the patient diary.
Blood samples will be taken for the investigations such as blood glucose (fasting, 30min \& 2hr after meal), HbA1c, Plasma insulin (fasting, 30min \& 2hr after meal), C peptide (2hr after meal), fasting serum Amylase, Lipase, Urea, Creatinine, GGT, Urine albumin/creatinine ratio and Urine pregnancy test(if required) as specified in visit chart below. There will be three telephonic visits on week 36, week 60 and week 84. During those visits subject will be inquired about the health status over the phone and the drugs for the next three months will be dispensed by courier or delivered at home by the coordinator.
If the glycaemic control is constantly not satisfactory (HbA1c ≥ 8.5%) from visit 3, a rescue drug (Glimepiride) will be added to both arms and all the clinical and biochemical test will be done as per visit chart. With Glimepiride if the A1C is >9% insulin will be added and the subject will be withdrawn from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminTablet Metformin 1000 - 2500 mg/day for 96 weeks |
| Vildagliptin | Experimental | Drug: VildagliptinTablet Vildagliptin 100mg/day for 96 weeks |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Newly Diagnosed Type 2 Diabetes Mellitus patients not receiving any medication for diabetes
- HbA1c ranging from 7.0% to ≤ 8.5%
- Body Mass Index (BMI) ≥ 19.0 to ≤ 25.0 kg/m2
- Male and female subjects of age between 20 - 60 years shall be selected
- Adult subjects willing to give informed consent
Key exclusion criteria (22 listed)
- Type 1 diabetes
- BMI ≤18.99 kg/m2 or> 25 kg/m2
- Presence of severe vascular complications
- Indications for use of insulin
- Elevated serum levels of lipase and amylase (>1.5 ULN)
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 |
|---|---|---|
| MetforminParticipant will be instructed to take Metformin tablets as per instructions given by the physician. | Drug | Metformin |
| VildagliptinParticipant will be instructed to take one tablet of Vildagliptin 50mg per day, 30 minutes after breakfast in the morning and second tablet at night, 30 minutes after dinner | Drug | Vildagliptin |
Primary outcome
Changes in Insulin secretion rate
Time frame: Baseline and 96 weeks
To compare the effects of Vildagliptin versus Metformin on Pancreatic beta cell function in type 2 diabetic subjects as measure by Insulin secretion rate (ISR) relative to glucose0-2hr (pmol/min/m2/mmol/L)
10 secondary outcomes
Changes in HbA1c reduction
Time frame: Baseline and 96 weeks
Changes in C peptide response
Time frame: Baseline and 96 weeks
Changes in Insulin to glucose ratio
Time frame: Baseline and 96 weeks
Changes in Fasting plasma glucose
Time frame: Baseline and 96 weeks
Changes in 2hr postprandial plasma glucose
Time frame: Baseline and 96 weeks
Changes in Insulin sensitivity
Time frame: Baseline and 96 weeks
Changes in Oral disposition index
Time frame: Baseline and 96 weeks
Percentage of subjects reaching HbA1c ≤ 6.5%
Time frame: Baseline and 96 weeks
Percentage of subjects reaching HbA1c ≤ 7.0%
Time frame: Baseline and 96 weeks
Number of participant treated related to adverse event
Time frame: Baseline and 96 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Derived from this study: PubMed 32501595Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
- Individual participant dataSharing planned: Undecided
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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.
Ambady Ramachandran, MD,Ph.D,D.Sc principal investigator
President, India Diabetes Research Foundation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin and Vildagliptin in people with TYpe 2 Diabetes Mellitus, run by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals at 6 sites in India.
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 8 inclusion and 22 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 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Insulin secretion rate (time frame: Baseline and 96 weeks). 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 NCT02853630, which also lists 1 linked publication.
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 2 Apr 2019.