Diabetes mellitus type 2 MedDRA version: 16.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Lyxumia® 10µg
Pharmaceutical Form: Solution for injection in cartridge
INN or Proposed INN: LIXISENATIDE
CAS Number: 320367-13-3
Other descriptive name: LIXISENATIDE
Concentration unit: µg
Sponsors
Profil Institut für Stoffwechselforschung GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, between 18 and 75 years of age, inclusive. 2. Body mass index between 20.0 and 40.0 kg/m2, inclusive. 3. Male or female subjects with type 2 diabetes mellitus for at least 1 year at the time of the screening visit, not adequately controlled under therapy with metformin or metformin plus sulfonylurea, DPPIV inhibitor and dapagliflozin (FPG > 7.8 mmol·L-1, HbA1c (glycosylated hemoglobin) =7.0% and HbA1c =9.5% at screening) 4. If female, subject must use a double contraception method, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. The accepted double contraception methods include use of a highly effective method of birth control (intrauterine device or hormonal contraception) in addition to one of the following contraceptive options: (1) condom; (2) diaphragm or cervical/vault cap; (3) spermicide. 5. Having given written informed consent prior to undertaking any study-related procedure. 6. Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research. Not under any administrative or legal supervision. 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 23 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: 1. Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis 2. Current or previous treatment with insulin (except for treatment within a clinical trial, for surgical procedures or during an acute illness for = 7 days and more than 14 days before the first administration of study drug) 3. Treatment with any hypoglycaemic medication other than metformin or metformin combined with sulfonylurea, DPPIV inhibitor or dapagliflozin within the three months prior to screening. Exception: treatment with a glitazone for ? 4 weeks and more than three months prior to screening. 4. FPG ? 13.9 mmol·L-1 at screening or before randomisation (V2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To address in type 2 diabetic patients compared to baseline the effect of repeated doses of Lyxumia® and Lantus® after an eight weeks two-step treatment regimen (four weeks administration of either Lyxumia® or Lantus®, both followed by their combined administration for another four weeks) on - intravenous glucose tolerance test (IVGTT) related first phase insulin secretion;Secondary Objective: To address in type 2 diabetes patients compared to baseline the effect 1. of repeated doses of Lyxumia® and Lantus® after an eight weeks two step treatment regimen (four weeks administration of either Lyxumia® or Lantus®, followed by combined administration for another four weeks) 2. of treatment sequence (four weeks administration of Lyxumia® vs. four weeks administration of Lantus®, both followed by a combined administration for another four weeks) glucagon, as well as serum levels of free fatty acids, TGs, and on gastric emptying To assess Lyxumia® safety and tolerability as add on treatment to Lantus® and metformin;Primary end point(s): AUCISEC(0-10min) First phase insulin secretion – area under the insulin secretion rate-time curve within 0 to 10 min after iv glucose challenge;Timepoint(s) of evaluation of this end point: end of trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints (IVGTT-related) AUCISEC(10-120min) Second phase insulin secretion – area under the insulin secretion rate-time curve within 10 to 120 min after iv glucose challenge AUCC-PEP(0-10min) Area under the C-peptide concentration-time curve within 0 to 10 min after iv glucose challenge AUCC-PEP(10-120min) Area under the C-peptide concentration - time curve within 10 to 120 min after iv glucose challenge AUCC-PEP (0-120min) Area under the C-peptide concentration - time curve within 0 to 120 min after iv glucose challenge AUCGLU(0-120min) Area under the plasma glucose concentration - time curve within 0 to 120 min after iv glucose challenge Key secondary endpoints [13C-MMTT (both breakfast and late lunch)-related] AUCGLU(0-240min) Area under the plasma glucose concentration - time curve within 0 to 240 min after starting meal ingestion AUCINS(0-240min) Area under the plasma insulin concentration - time curve within 0 to 240 min after starting meal ingestion AUCC-PEP(0-240 min) Area under the plasma C-peptide concentration - time curve within 0 to 240 min after starting meal ingestion AUCGCN(0-240min) Area under the plasma glucagon concentration - time curve within 0 to 240 min after starting meal ingestion AUCFFA(0-240min) Area under the serum free fatty acid concentration - time curve within 0 to 240 min after starting meal Ingestion AUCTG(0-240min) Area under the serum triglyceride concentration - time curve within 0 to 240 min after starting meal ingestion t1/2, tlag, GEC Mean half emptying time (t1/2 ), lag phase (tlag) and gastric emptying coefficient (GEC) after meal Fasting plasma glucose (FPG), SMPG, 7-point SMPG profiles, fasting cholesterol, LDL and HDL, HbA1c, body weight Secondary endpoints (safety) Clinical laboratory, ECG parameters, vital signs, adverse events and serious adverse events (including in particular symptomatic and severe symptomatic hypoglycemia, local intolerability at | — |
Countries
Germany
Contacts
Public ContactRegulatory Affairs
Profil Institut für Stoffwechselforschung GmbH
Outcome results
None listed