E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To quantify differences in control of glycaemia |
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E.2.2 | Secondary objectives of the trial |
To quantify the secretion of endogenous incretin hormones and their effects on insulin and glucagon secretion |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Incremental area under the plasma glucose (BG) concentration-time profile (AUC) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
immediately before to 300 min after a mixed meal test |
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E.5.2 | 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 |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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the date when the clean data base is available |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |