Diabetes mellitus type 2 MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Januvia
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sitagliptin
CAS Number: 654671-77-9
Other descriptive n
Sponsors
Profil Institut für Stoffwechselforschung GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female subject with diabetes mellitus type 2. • Age between 18 and 64 years, both inclusive. • HbA1c = 1500 mg/day or at highest tolerated dose) for at least 3 months prior to inclusion into the trial with or without additional oral glucose-lowering agents (except thiazolidinediones). • Considered generally healthy (apart from diabetes mellitus type 2 and associated conditions such as hypertension, hyperlipidaemia and hyperuricaemia) upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator. 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Known or suspected hypersensitivity to sitagliptin or related products. • More than one episode of severe hypoglycaemia with seizure, coma or requiring medical assistance of another person during the past 6 months or hypoglycaemic unawareness as judged by the Investigator. • Current or previous treatment (less than 3 months prior to screening) with insulin products other than insulin glargine and/or with GLP-1 receptor agonists and/or with thiazolidinediones. • Unwillingness to wash-off any oral glucose-lowering agents other than metformin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to test the influence of DPP-4 inhibition (comparing sitagliptin 100 mg per day versus placebo in a cross-over design) on (a) the risk to develop hypoglycemia and on (b) hormonal responses and recovery from hypoglycemia in the case that they occur ;Secondary Objective: not applicable;Primary end point(s): • The difference between sitagliptin and placebo treatment regarding the number of hypoglycaemic episodes characterized by a plasma glucose nadir of = 70 mg/dl (i.e. in chemical hypoglycaemic episodes) occurring during the in-house period.;Timepoint(s) of evaluation of this end point: during the in-house period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The difference between sitagliptin and placebo treatment regarding the number of any (confirmed or not) symptomatic hypoglycaemic episodes or regarding asymptomatic hypoglycaemia occurring during the in-house period. 2. The time spent at an interstitial (plasma-calibrated) glucose concentration = 70 mg/dl as determined by CGM. 3. The concentration of counter-regulatory hormones (first of all, glucagon) at times when plasma glucose is = 70 mg/dl, as well as 30 and 60 min later will be compared between sitagliptin and placebo treatment. 4. The rise in glucose between the index time point and 30 and 60 min later (taking into account any compensatory oral carbohydrate administration). ; Timepoint(s) of evaluation of this end point: 1. during the in-house period 2. as determined by CGM 3. at times when plasma glucose is = 70 mg/dl, , as well as 30 and 60 min later 4. between the index time point and 30 and 60 min later | — |
Countries
Germany
Contacts
Public ContactProject Development
Profil Institut für Stoffwechselforschung GmbH
Outcome results
None listed