Single-centre, Randomised, Double-blind, Placebo-controlled, Four-way Crossover Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Doses of CM3.1-AC100 in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The primary objective of this study is to assess the safety and tolerability of the Glucagon-like peptide-1 (GLP-1) peptide analogue CM3.1-AC100 after single subcutaneous (sc) doses in patients with T2DM.

Official Title
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Single-centre, Randomised, Double-blind, Placebo-controlled, Four-way Crossover Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Doses of CM3.1-AC100 in Patients With Type 2 Diabetes

Conditions
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Type II Diabetes Mellitus

Intervention / Treatment
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* Drug: CM3.1-AC100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent prior to any study specific procedures Type 2 diabetes mellitus patient, diagnostically confirmed since at least 6 months Male or female patient aged 18 to 75 years at screening, both inclusive BMI >22 to ≤40 kg/m2 at screening Exclusion Criteria: Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, eg Cushings's syndrome and acromegaly Fasting C-peptide < 500 pM at screening Acute gastrointestinal symptoms at the time of screening and/or Day -1 Any clinically relevant history or the presence of cardiovascular, bronchopulmonary, gastrointestinal or neurological diseases inclusive history of chronic pancreatitis or acute pancreatitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM3.1-AC100 dose A<br>Compound CM3.1-AC100 s.c. | Drug: CM3.1-AC100<br>* SAD study with single ascending subcutaneous doses<br>|
| Experimental: CM3.1-AC100 dose B<br>Compound CM3.1-AC100 s.c. | Drug: CM3.1-AC100<br>* SAD study with single ascending subcutaneous doses<br>|
| Experimental: CM3.1-AC100 dose C<br>Compound CM3.1-AC100 s.c. | Drug: CM3.1-AC100<br>* SAD study with single ascending subcutaneous doses<br>|
| Placebo Comparator: Placebo<br>Placebo for compound CM3.1-AC100 s.c. | Drug: CM3.1-AC100<br>* SAD study with single ascending subcutaneous doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measurements | AEs, ECGs, BP, pulse, body temperature, laboratory variables, local tolerability including a VAS score for local pain, Present Nausea Intensity (PNI) by a nausea questionnaire and a VAS score of the Overall Nausea Index (ONI) | Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK samples for CM3.1-AC100 | Pharmacokinetics: AUC, AUC0-4h, AUC0-t, Cmax, tmax, t1/2lz, λz, CL/F, Vz/F of CM3.1-AC100 | Intense PK-sampling during the 24 hours following administration of CM3.1-AC100 |