NCT02725502

Brief Summary

Type 1 diabetes is an autoimmune disorder characterized by beta cell destruction resulting in insulinopenia. Currently it is being treated with insulin. Dipeptidylpeptidase inhibitors (DPP4 inhibitors e.g. linagliptin \& sitagliptin) has been used for type 2 diabetes mellitus (T2DM) traditionally. Previous studies has shown that it is also effective in type 1 diabetes mellitus (T1DM), but the mechanism of action not well understood. This study will evaluate possible mechanism of action of linagliptin in T1DM patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

January 20, 2014

Last Update Submit

March 31, 2016

Conditions

Type 1 Diabetes Mellitus

Keywords

T1DMLinagliptinmix meal test

Outcome Measures

Primary Outcomes (3)

  • Effect of Linagliptin on HbA1c in T1DM patients

    Change in HbA1C in linagliptin group as compared to placebo group

    After 3 months of the starting of the treatment

  • Effect of Linagliptin on glycemic variability in T1DM patients

    Change in glycemic variability (CGMS indices) in linagliptin group as compared to placebo group

    After 3 months of the starting of the treatment

  • Effect of Linagliptin on insulin requirement in T1DM patients

    Change in insulin requirement in linagliptin group as compared to placebo group

    After 3 months of the starting of the treatment

Secondary Outcomes (2)

  • Effect of linagliptin on GLP1 level during mixed meal test in T1DM patients

    after 3 months of the starting of the treatment

  • Effect of linagliptin on glucagon level during mixed meal test in T1DM patients

    after 3 months of the starting of the treatment

Study Arms (2)

Linagliptin treatment group

ACTIVE COMPARATOR

Group will receive linagliptin ( 5 mg / day ) for 3 months in addition to their insulin

Drug: Linagliptin

Placebo group

PLACEBO COMPARATOR

Group will receive placebo for 3 months in addition to their insulin

Drug: Placebo

Interventions

LinagliptinDRUG

Baseline HbA1C will be assessed. Before starting treatment with linagliptin or placebo Mixed meal test will be conducted with the standard protocol. Morning dose of insulin to be omitted on the day of mixed meal test. During the mixed meal test glucose, C-peptide, GLP1 and glucagon will be measured at 0, 30, 60, 120, 180 minutes. 72 hour blood glucose profile to be monitored with continuous glucose monitoring system (CGMS). Markers of glucose control and glucose variability will be measured. Then we will randomly divide these patients in two group (linagliptin and placebo group). After 3 month period 72 hour blood glucose profile, HbA1C and Mixed meal test will be repeated to document any change in blood glucose profile.

Linagliptin treatment group
PlaceboDRUG

Baseline HbA1C will be assessed. Before starting treatment with linagliptin or placebo. Mixed meal test will be conducted with the standard protocol. Morning dose of insulin to be omitted on the day of mixed meal test. During the mixed meal test glucose, C-peptide, GLP-1 and glucagon will be measured at 0, 30, 60, 120, 180 minutes. 72 hour blood glucose profile to be monitored with CGMS. Markers of glucose control and glucose variability will be measured. Then we will randomly divide these patients in two group (linagliptin and placebo group). After 3 month period 72 hour blood glucose profile, HbA1C and Mixed meal test will be repeated to document any change in blood glucose profile.

Placebo group

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male or female adult, aged 15 to 30 years
  • Duration of type 1 Diabetes Mellitus for 6 months or more, as established by medical history
  • Current treatment with multiple injections of insulin for at least 3 months prior to screening visit; and using the same insulin during the last 1 month
  • HbA1c \< 8%
  • Body mass index (BMI) \< 25 kg/mt2
  • Euthyroid patient. If thyroid dysfunction is present then thyroid function test (TFT) should be normal at the time of study ( with medication)

You may not qualify if:

  • On pramlintide, metformin, GLP1 agonist or DPP4 inhibitor. If taking this drugs then stop them 2 wk prior to study.
  • On prokinetics \& proton pump inhibitor (PPI). If taking this drugs then stop them 2 wk prior to study
  • Creatinine of \>1.5 mg/dl or a calculated creatinin clearance of \<50 ml/min or overt proteinuria.
  • Fasting blood glucose (FBG) \< 72 or \> 180 in the day of mixed meal test (MMT)
  • Pregnant
  • Seriously ill patients
  • Presence of gastroparesis ( if history is suggestive of autonomic neuropathy or gastroparesis then gastric emptying study to be done to rule it out)
  • Type 1 Diabetes Mellitus for less than 6 months duration
  • Presence of celiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology, PGIMER

Chandigarh, Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Linagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Study Officials

  • Sanjay Kr Bhadada, MD, DM

    Department of Endocrinology, PGIMER, Chnadigarh India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjay Kr Bhadada, MD, DM

CONTACT

9876602448bhadadask@rediffmail.com

Soham Mukherjee, MD

CONTACT

9914743222drsoham.mukherjee@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 20, 2014

First Posted

April 1, 2016

Study Start

July 1, 2013

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

April 1, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)