Type 2 Diabetes MellitusPhase 4NCT02097342
Effect of Linagliptin on Insulin Sensitivity and Pancreatic Beta Cell Function in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Linagliptin and Voglibose in people with Type 2 Diabetes Mellitus and Insulin Sensitivity/Resistance, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
This study is planned to evaluate if linagliptin can improve insulin sensitivity in patients with type 2 diabetes mellitus. In addition, the effect of linagliptin on pancreatic function will be studied. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Insulin Sensitivity/Resistance
- What is being tested?
- Linagliptin and Voglibose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2013to Jan 2015
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus (according to ADA guidelines)
- Age between 30-65 years
- Duration of diabetes less than five years
- BMI of between 20 and 40 kg/m2
- HbA1c level of < 7.5%
- On metformin monotherapy for at least 6 weeks
Who cannot join
- History of ketoacidosis
- Hepatic impairment (defined as plasma aminotransferase elevations of more than 3 times upper limit of normal)
- Renal failure (defined as Serum Creatinine more than 1.5 mg/dl)
- Coronary artery disease or heart failure
- Cerebrovascular disease or stroke
- Anemia (Hb< 10 g/dl)
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- Those who requires insulin therapy HbA1c >7.5%
- Presence of macular edema
- Pregnant or lactating women
- Patients who have received dipeptidyl peptidase 4 (DPP-4) inhibitor therapy within last 3 months
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Postgraduate Institute of Medical Education & Research
Chandigarh, Chandigarh, 160012
Anil Bhansali, MD DM, anilbhansaliendocrine@gmail.com
About this study
Official title: A Randomized Double-blind Study to Evaluate the Effect of Linagliptin on Pancreatic Beta Cell Function and Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy
This study is planned to evaluate if linagliptin can improve insulin sensitivity in patients with type 2 diabetes mellitus. In addition, the effect of linagliptin on pancreatic function will be studied.
Read the detailed description
This is a prospective study of 30 patients with type 2 diabetes mellitus (T2DM) . Patients with T2DM in the age group 30-65 years and duration of diabetes less than five years will be screened. After exclusion, those who meet the inclusion criteria will be included in the study.
Once eligibility criteria are confirmed, patients will be educated about their disease and will be advised weight maintenance diabetic diet and exercise throughout the study period. Patients will be randomized to three groups - linagliptin (5mg OD) or voglibose (0.2mg TDS) or placebo OD. Metformin will be continued in all patients. To evaluate the effect of linagliptin on insulin sensitivity and beta cell function, independent of changes in HbA1c, the voglibose group is included. Each group will have 10 patients and will be followed up for 6 months. Both patients and physicians will be blinded to the treatment.
After having written informed consent, a detailed history and a thorough clinical examination will be done in all subjects including measurement of height, weight, body mass index and waist circumference. Hemoglobin, liver function tests, renal function tests, lipid profile, HbA1c, fasting plasma insulin , C-peptide, homeostasis model assessment-insulin resistance index(HOMA-1R) and homeostasis model assessment-beta cell function index (HOMA-β) will be done at baseline. A euglycemic hyperinsulinemic clamp study and a mixed meal test will be performed in all patients (on different days) at baseline and after 6 months of follow up. Biochemical parameters will be measured again 6 months after therapy. Fasting and post-prandial blood glucose will be done monthly for 6 months.
- Being tested
- Linagliptin, Placebo, Voglibose
- Keywords
- Type 2 Diabetes Mellitus, Insulin sensitivity- hyperinsulinemic euglycemic clamp, Pancreatic beta cell function, Linagliptin, Voglibose, Mixed meal test, GLP-1 response
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinagliptinDrug
Also called Trajenta 5mg
Tablet Linagliptin (5mg) per oral, once daily will be given to 10 patients for 6 months
PlaceboDrug
Tablet placebo per oral, once daily will be given to 10 patients for 6 months
VogliboseDrug
Tablet Voglibose (0.2mg) per oral thrice daily(with meals) to 10 patients for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Linagliptin | Experimental | Tablet Linagliptin (5mg) per oral, once daily will be given to 10 patients for 6 months Receives: Drug: Linagliptin |
| Placebo | Placebo comparator | Tablet Placebo per oral, once daily will be given to 10 patients for 6 months Receives: Drug: Placebo |
| Voglibose | Active comparator | Tablet Voglibose (0.2mg) per oral, thrice daily (with meals) will be given to 10 patients for 6 months Receives: Drug: Voglibose |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the effect of Linagliptin on insulin sensitivity by performing euglycemic hyperinsulinemic clamp in patients with type 2 diabetes mellitus.
Hyperinsulinemic euglycemic clamp of 2 hours duration will be done at baseline and after 6 months of treatment in all patients. Medications taken by the patient will be omitted on the day of test.After an overnight fast of 10 hours, intravenous catheter will be inserted, under sterile precautions, into the antecubital vein for infusion of insulin and dextrose solutions, while another catheter will be inserted in an anti-flow direction into the dorsal vein of the contralateral hand for arterialized blood sampling.
An insulin infusate of 300 mU/ml will be administered at a constant rate, after an initial priming dose, while a 25 percent dextrose solution is administered at varying rates to maintain blood glucose at 90 mg/dl. Blood glucose will be analyzed by a bedside glucose analyzer every 5 minutes. M value, a measure of glucose utilisation will be calculated during the steady state (last 30 minutes of the test)
Measured: 6 months
Secondary outcomes (1)
To study the effects of Linagliptin on glycemic control and beta cell function in patients with type 2 diabetes mellitus 6 months
Fasting and 2 hour postprandial blood glucose will be at baseline and after 6 months of treatment. HbA1C will be done at baseline and after 3 and 6 months.
HOMA-IR and HOMA-β will be done at baseline and after 6 months. Patients will also be subjected to a mixed meal test at baseline and at 6 months. Mixed meal test will be done 3-7 days after clamp study. After an overnight fast of 10 hours, patients will be given standardized mixed meal, 2.5 g/ kg. (Ensure, Abbott Nutrition, Abbott Laboratories) Medications normally taken by the subject in the morning will be administered 20 min prior to the start of the test meal. Samples for glucose, insulin, C-peptide and glucagon-like peptide-1 (GLP-1) will be taken at 0,30,60,90,120,150 and 180 minutes following the ingestion of meal. Total area under curves for glucose, insulin, C-peptide and GLP-1 from pre meal to 180 min will be calculated using the trapezoidal rule.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2014 (estimated)
- Study completionJan 2015 (estimated)
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Bhansali, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097342
- Sponsor's protocol ID
- Linagliptin
- Status last verified
- Apr 2014
- First submitted
- 24 Mar 2014
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parthan G, Bhansali S, Kurpad AV, Walia R, Bhat K, Bhansali A. Effect of Linagliptin and Voglibose on metabolic profile in patients with Type 2 Diabetes: a randomized, double-blind, placebo-controlled trial. BMC Pharmacol Toxicol. 2018 Jul 3;19(1):38. doi: 10.1186/s40360-018-0228-z.
PubMed 29970184
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Study to Evaluate the Effect of Linagliptin on Pancreatic Beta Cell Function and Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy
- ClinicalTrials.gov ID
- NCT02097342
- Acronym / sponsor ID
- Linagliptin
- Keywords
- Type 2 Diabetes Mellitus, Insulin sensitivity- hyperinsulinemic euglycemic clamp, Pancreatic beta cell function, Linagliptin, Voglibose, Mixed meal test, GLP-1 response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 27 Mar 2014 (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 planned to evaluate if linagliptin can improve insulin sensitivity in patients with type 2 diabetes mellitus. In addition, the effect of linagliptin on pancreatic function will be studied.
Detailed description
This is a prospective study of 30 patients with type 2 diabetes mellitus (T2DM) . Patients with T2DM in the age group 30-65 years and duration of diabetes less than five years will be screened. After exclusion, those who meet the inclusion criteria will be included in the study.
Once eligibility criteria are confirmed, patients will be educated about their disease and will be advised weight maintenance diabetic diet and exercise throughout the study period. Patients will be randomized to three groups - linagliptin (5mg OD) or voglibose (0.2mg TDS) or placebo OD. Metformin will be continued in all patients. To evaluate the effect of linagliptin on insulin sensitivity and beta cell function, independent of changes in HbA1c, the voglibose group is included. Each group will have 10 patients and will be followed up for 6 months. Both patients and physicians will be blinded to the treatment.
After having written informed consent, a detailed history and a thorough clinical examination will be done in all subjects including measurement of height, weight, body mass index and waist circumference. Hemoglobin, liver function tests, renal function tests, lipid profile, HbA1c, fasting plasma insulin , C-peptide, homeostasis model assessment-insulin resistance index(HOMA-1R) and homeostasis model assessment-beta cell function index (HOMA-β) will be done at baseline. A euglycemic hyperinsulinemic clamp study and a mixed meal test will be performed in all patients (on different days) at baseline and after 6 months of follow up. Biochemical parameters will be measured again 6 months after therapy. Fasting and post-prandial blood glucose will be done monthly for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Linagliptin | Experimental | Drug: LinagliptinTablet Linagliptin (5mg) per oral, once daily will be given to 10 patients for 6 months |
| Placebo | Placebo comparator | Drug: PlaceboTablet Placebo per oral, once daily will be given to 10 patients for 6 months |
| Voglibose | Active comparator | Drug: VogliboseTablet Voglibose (0.2mg) per oral, thrice daily (with meals) will be given to 10 patients for 6 months |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with type 2 diabetes mellitus (according to ADA guidelines)
- Age between 30-65 years
- Duration of diabetes less than five years
- BMI of between 20 and 40 kg/m2
- HbA1c level of < 7.5%
Key exclusion criteria (10 listed)
- History of ketoacidosis
- Hepatic impairment (defined as plasma aminotransferase elevations of more than 3 times upper limit of normal)
- Renal failure (defined as Serum Creatinine more than 1.5 mg/dl)
- Coronary artery disease or heart failure
- Cerebrovascular disease or stroke
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 |
|---|---|---|
| LinagliptinAlso: Trajenta 5mgTablet Linagliptin (5mg) per oral, once daily will be given to 10 patients for 6 months | Drug | Linagliptin |
| PlaceboTablet placebo per oral, once daily will be given to 10 patients for 6 months | Drug | Placebo |
| VogliboseTablet Voglibose (0.2mg) per oral thrice daily(with meals) to 10 patients for 6 months | Drug | Voglibose |
Primary outcome
To study the effect of Linagliptin on insulin sensitivity by performing euglycemic hyperinsulinemic clamp in patients with type 2 diabetes mellitus.
Time frame: 6 months
Hyperinsulinemic euglycemic clamp of 2 hours duration will be done at baseline and after 6 months of treatment in all patients. Medications taken by the patient will be omitted on the day of test.After an overnight fast of 10 hours, intravenous catheter will be inserted, under sterile precautions, into the antecubital vein for infusion of insulin and dextrose solutions, while another catheter will be inserted in an anti-flow direction into the dorsal vein of the contralateral hand for arterialized blood sampling. An insulin infusate of 300 mU/ml will be administered at a constant rate, after an initial priming dose, while a 25 percent dextrose solution is administered at varying rates to maintain blood glucose at 90 mg/dl. Blood glucose will be analyzed by a bedside glucose analyzer every 5 minutes. M value, a measure of glucose utilisation will be calculated during the steady state (last 30 minutes of the test)
1 secondary outcome
To study the effects of Linagliptin on glycemic control and beta cell function in patients with type 2 diabetes mellitus 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Derived from this study: PubMed 29970184Parthan G, Bhansali S, Kurpad AV, Walia R, Bhat K, Bhansali A. Effect of Linagliptin and Voglibose on metabolic profile in patients with Type 2 Diabetes: a randomized, double-blind, placebo-controlled trial. BMC Pharmacol Toxicol. 2018 Jul 3;19(1):38. doi: 10.1186/s40360-018-0228-z.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Linagliptin and Voglibose in people with Type 2 Diabetes Mellitus and Insulin Sensitivity/Resistance, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site 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 6 inclusion and 10 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 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anil Bhansali, MD DM (01722756580, anilbhansaliendocrine@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the effect of Linagliptin on insulin sensitivity by performing euglycemic hyperinsulinemic clamp in patients with type 2 diabetes mellitus. (time frame: 6 months). 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 NCT02097342, 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 8 Apr 2014.