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Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Linagliptin
Placebo
Empagliflozin
Sponsored by
Profil Institut für Stoffwechselforschung GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female subject with diabetes mellitus type 2
  2. Diabetes mellitus type 2 on stable treatment with metformin (daily dose at least 1000 mg) for at least 6 months
  3. HbA1c 7.0%-9.9%, both inclusive
  4. Diabetes duration of at least 24 months)

Exclusion Criteria:

  1. History of diabetes mellitus type 1
  2. GFR (as calculated by the Cockcroft-Gault equation) < 60 ml/min at Screening
  3. Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 95 mmHg at Screening

Sites / Locations

  • Profil Mainz GmbH & Co. KG
  • Profil Institut für Stoffwechselforschung GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Other

Arm Label

Empagliflozin plus Linagliptin

Empagliflozin plus Placebo

Empagliflozin

Arm Description

Linagliptin 5mg to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin

Placebo to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin

Empagliflozin 25mg will be adminstered for 30 days in T2DM patients

Outcomes

Primary Outcome Measures

• Change in glucagon release (AUC0-180 min) during Liquid Meal Test (LMT) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo)

Secondary Outcome Measures

• Change in glucagon release (AUC0-180 min) during LMT from V2 to V3 during treatment with Empagliflozin (V2 vs. V3)

Full Information

First Posted
December 11, 2014
Last Updated
February 23, 2016
Sponsor
Profil Institut für Stoffwechselforschung GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02401880
Brief Title
Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology
Official Title
Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology and Metabolic Control in Patients With Type 2 Diabetes Mellitus on Stable Metformin Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Profil Institut für Stoffwechselforschung GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of this exploratory mechanistic study is to investigate the effects of Empagliflozin and Linagliptin on alpha- and beta cell physiology in T2DM patients. This study aims to evaluate the effect of the DPP-IV inhibitor linagliptin (as compared to placebo) in addition to the SGLT-2 inhibitor empagliflozin on pancreatic alpha and beta cell function, as well as several markers of metabolic control.
Detailed Description
This study will be performed as a multi-center study which includes 2 centres. 44 subjects with T2DM are to be included according to the defined in- and exclusion criteria. Subjects has to be on a stable metformin therapy and will receive in a first step empagliflozin for 30 days. Both therapies (metformin and empagliflozin) will be continued for another 30 days and subjects will be randomized to receive in addition Linagliptin or Placebo for 30 days. Subjects will come for two inhouse periods to their corresponding study center and will undergo an hyperglycaemic clamp test as well as a Meal test in each of the periods.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Empagliflozin plus Linagliptin
Arm Type
Active Comparator
Arm Description
Linagliptin 5mg to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
Arm Title
Empagliflozin plus Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to be adminstered for 30 days in T2DM patients on stable metformin and Empagliflozin
Arm Title
Empagliflozin
Arm Type
Other
Arm Description
Empagliflozin 25mg will be adminstered for 30 days in T2DM patients
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Other Intervention Name(s)
Trajenta
Intervention Description
22 subjects will receive Linagliptin for 30 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
22 subjects will receive Placebo for 30 days
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Other Intervention Name(s)
Jardiance
Intervention Description
44 subjects will receive Empagliflozin for 60 days
Primary Outcome Measure Information:
Title
• Change in glucagon release (AUC0-180 min) during Liquid Meal Test (LMT) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
• Change in glucagon release (AUC0-180 min) during LMT from V2 to V3 during treatment with Empagliflozin (V2 vs. V3)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subject with diabetes mellitus type 2 Diabetes mellitus type 2 on stable treatment with metformin (daily dose at least 1000 mg) for at least 6 months HbA1c 7.0%-9.9%, both inclusive Diabetes duration of at least 24 months) Exclusion Criteria: History of diabetes mellitus type 1 GFR (as calculated by the Cockcroft-Gault equation) < 60 ml/min at Screening Systolic blood pressure outside the range of 100-160 mmHg or diastolic blood pressure above 95 mmHg at Screening
Facility Information:
Facility Name
Profil Mainz GmbH & Co. KG
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Profil Institut für Stoffwechselforschung GmbH
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

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Effects of Linagliptin in Addition to Empagliflozin on Islet Cell Physiology

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