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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004895-48-DE

Enrollment

Unknown

Registered

2015-03-12

Start date

2015-05-06

Completion date

Unknown

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus MedDRA version: 17.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Jardiance Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Empagliflozin CAS Number: 864070-44-0 Other descriptive name: EMPAGLIFLOZIN Concentration unit: mg milligram(s) Conce

Eligibility

Sex/Gender

All

Inclusion criteria

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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12

Exclusion criteria

Exclusion criteria: 1. History of diabetes mellitus type 1 2. GFR (as calculated by the Cockroft-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

Design outcomes

Primary

Measure	Time frame
Main Objective: • To evaluate alpha- and beta-cell function during treatment with linagliptin in addition to empagliflozin and metformin compared to placebo in addition to empagliflozin and metformin in subjects with T2DM on stable metformin background therapy • To evaluate the effect of empagliflozin treatment on alpha- and beta-cell function in subjects with T2DM on stable metformin background therapy • To evaluate insulin resistance during treatment with empagliflozin plus linagliptin compared to empagliflozin alone in subjects with T2DM on stable metformin background therapy ;Secondary Objective: Not applicable;Primary end point(s): • Change in glucagon release (AUC0-180 min) during Liquid Meal Test (LMT) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo) (Glucagon release was basis for sample size calculation) • Change in glucagon release (AUC0-180 min) during LMT from V2 to V3 during treatment with Empagliflozin (V2 vs. V3) • Change in Glucagon/Insulin ratio (AUC0-180 min) during LMT from V3 to V4 between the two treatment groups (Linagliptin vs. placebo) •Change in first phase glucagon/insulin ratio during hyperglycemic clamp investigation (AUC0-10min) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo) • Change in intact proinsulin release (AUC0-180 min) during LMT from V3 to V4 between the two treatment groups (Linagliptin vs. placebo) ;Timepoint(s) of evaluation of this end point: 0-180 or 0-10 min after trial drug administration as given above	—

Measure

Time frame

Main Objective: • To evaluate alpha- and beta-cell function during treatment with linagliptin in addition to empagliflozin and metformin compared to placebo in addition to empagliflozin and metformin in subjects with T2DM on stable metformin background therapy • To evaluate the effect of empagliflozin treatment on alpha- and beta-cell function in subjects with T2DM on stable metformin background therapy • To evaluate insulin resistance during treatment with empagliflozin plus linagliptin compared to empagliflozin alone in subjects with T2DM on stable metformin background therapy ;Secondary Objective: Not applicable;Primary end point(s): • Change in glucagon release (AUC0-180 min) during Liquid Meal Test (LMT) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo) (Glucagon release was basis for sample size calculation) • Change in glucagon release (AUC0-180 min) during LMT from V2 to V3 during treatment with Empagliflozin (V2 vs. V3) • Change in Glucagon/Insulin ratio (AUC0-180 min) during LMT from V3 to V4 between the two treatment groups (Linagliptin vs. placebo) •Change in first phase glucagon/insulin ratio during hyperglycemic clamp investigation (AUC0-10min) from V3 to V4 between the two treatment groups (Linagliptin vs. placebo) • Change in intact proinsulin release (AUC0-180 min) during LMT from V3 to V4 between the two treatment groups (Linagliptin vs. placebo) ;Timepoint(s) of evaluation of this end point: 0-180 or 0-10 min after trial drug administration as given above

—

Secondary

Measure	Time frame
Secondary end point(s): Treatment-emergent hypoglycaemic episodes, changes in clinical variables, incidence of Adverse Events;Timepoint(s) of evaluation of this end point: ongoing during the trial	—

Countries

Germany

Contacts

Public ContactDr. Christoph Kapitza

Profil Institut für Stoffwechselforschung GmbH

christoph.kapitza@profil.com+4921314018157

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026