TYPE 2 DIABETES 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: Januvia
Pharmaceutical Form: Tablet
INN or Proposed INN: SITAGLIPTIN
CAS Number: 654671-77-9
Other descriptive name: SITAGLIPTIN PHOSPHATE MONOHYDRATE
Concentration unit: mg milligram(s)
Sponsors
Diabeteszentrum Bad Lauterberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female subjects with a diagnosis of type 2 diabetes mellitus according to ADA criteria at least 4 months prior to screening. - On a stable regimen of metformin for at least 1 month and liraglutide 1.2 mg for at least 1 week at the time-point of randomisation. - Aged between 25 and 75 years, both inclusive. - Body mass index (BMI) between 22 and 40kg/m2, both inclusive - HbA1c = 6.5 and = 8.5% - Female must be post-menopausal, surgically sterilized or practicing an effective birth control 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 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: - Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis - Current or previous treatment with insulin therapy - Treatment with any hypoglycaemic medication other than metformin and liraglutide within one month prior to screening - Subjects with known diabetic gastroparesis - Subjects that underwent surgery of the upper gastrointestinal tract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To quantify differences in control of glycaemia ;Secondary Objective: To quantify the secretion of endogenous incretin hormones and their effects on insulin and glucagon secretion ;Primary end point(s): Incremental area under the plasma glucose (BG) concentration-time profile (AUC) ;Timepoint(s) of evaluation of this end point: immediately before to 300 min after a mixed meal test | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a_area under the insulin concentration-time profile b_area under the C-peptide concentration-time profile c_area under the glucagon concentration-time profile d_area under the total GLP-1 concentration-time profile e_area under the active GLP-1 concentration-time profile f_area under the total GIP concentration-time profile g_area under the active GIP concentration-time profile h_plasma glucose i_velocity of gastric emptying j_velocity of gastric emptying k_velocity of gastric emptying l_velocity of gastric emptying ;Timepoint(s) of evaluation of this end point: a-g: immediately before to 300 min following the mixed meal test h: 120 minutes after starting the meal i: as determined by t½ j: as determined by lag time k: as determined by gastric emptying coefficient l: as determined by time course | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Nauck
Diabeteszentrum Bad Lauterberg
Outcome results
None listed