Type 2 diabetes mellitus
Conditions
Brief summary
Incidence and severity of gastrointestinal adverse events as assessed by a symptom score, Frequency of gastrointestinal adverse events per participant
Detailed description
Change From Baseline in Glycated Hemoglobin (HbA1c), Change from Baseline in Mean Daily Plasma Glucose (PG), Changes in metabolic parameters (e.g. glucagon, C-peptide, insulin), Change from Baseline in body weight and waist circumference, Change from Baseline in lipid profile (TG, TC, HDL, LDL, VLDL), Pharmacokinetics of GL0034, Safety endpoints (e.g. adverse events others than gastrointestinal events, clinical laboratory parameters)
Interventions
DRUGGL0034 4 mg/ml
DRUG1 ml per vial
DRUGGL0034 3 mg/ml
DRUGSame solution as for GL0034 without drug substance; solution for subcutaneous injection; volume identical to dose of test product
DRUGGL0034 1mg/ml
DRUG0.6ml per vial
DRUGGL0034 1 mg/ml
Sponsors
Sun Pharmaceutical Industries Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of gastrointestinal adverse events as assessed by a symptom score, Frequency of gastrointestinal adverse events per participant | — |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Glycated Hemoglobin (HbA1c), Change from Baseline in Mean Daily Plasma Glucose (PG), Changes in metabolic parameters (e.g. glucagon, C-peptide, insulin), Change from Baseline in body weight and waist circumference, Change from Baseline in lipid profile (TG, TC, HDL, LDL, VLDL), Pharmacokinetics of GL0034, Safety endpoints (e.g. adverse events others than gastrointestinal events, clinical laboratory parameters) | — |
Countries
Germany
Outcome results
None listed