Diabetes type I MedDRA version: 6,1 Level: LLT Classification code 10045228
Conditions
Interventions
Product Name: MM005-Granulae
Product Code: MM005-Granulae
Pharmaceutical Form: Granules
INN or Proposed INN: Maydis amylum (Corn starch)
CAS Number: 9005-28-8
Other descriptive name: uncooked cornst
Sponsors
Metcon Medicin AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 20 to = 70 years 2. Informed consent given and signed 3. Type 1 diabetes, treated with short acting insulin (including insulin analogues) and or intermediate- and or long acting insulin (including insulin analogues). 4. A history of hypoglycemic events, i.e. subjects who regularly (at least 4 times/month during the last 3 months) experience plasma glucose =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Clinically significant symptoms of autonomic neuropathy experienced by the subject 2. Untreated proliferative retinopathy 3. Nephropathy (P-creatinine = 150 mmol/L based on sample taken at enrollment visit) 4. Use of medication known to influence gastrointestinal motility (presently or during the past 4 weeks) 5. Untreated hypertension (systolic blood pressure = 160 mm Hg and/or diastolic blood pressure = 95 mm Hg) 6. Cardiac insufficiency (severity grade II or higher according to NYHA) 7. Ischemic heart disease (severity grade II or higher according to NYHA) 8. Pregnancy* or lactation or intention to become pregnant during the study period.(*Women of childbearing potential are excluded unless a negative test for pregnancy has been obtained.) 9. Increased liver enzymes (ASAT or ALAT or alkaline phosphatase or bilirubin 2.5 times above the upper reference value based on sample taken at enrollment visit) 10. Suspected alcohol or drug abuse 11. Inability to understand information or comply with the study procedures 12. Participation in another clinical intervention study within 30 days prior to enrollment 13. Gastrointestinal inflammatory diseases including celiaki 14. Untreated hypothyroidism (diagnosed by TSH assay based on sample taken at enrollment visit)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy of MM005-Granulae in doses of 20 g and 30 g compared to placebo as prophylaxis for nocturnal hypoglycemia in insulin treated Type 1 diabetic subjects with a history of biochemical hypoglycemic events. ;Secondary Objective: (1) To assess the safety and tolerability of MM005-Granulae (2) To assess the change from baseline in HbA1C after eight weeks’ treatment with MM005-Granulae compared to placebo (3) To assess the change from baseline in HbA1C, comparing MM005-Granulae and placebo at follow-up, i.e. 30-37 days after end of treatment. (4) To assess the change from baseline in the lipid profile (cholesterol, LDL and HDL cholesterol, triglycerides and apolipoproteins A1 and B) after eight weeks’ treatment with MM005-Granulae compared to placebo (5) To assess the proportion of time with P-glucose <3.3 mmol/L during the six nights with CGMS recordings. All comparisons will be performed (a) between active treatment and placebo and (b) between 20 g, 30 g and placebo. ;Primary end point(s): The primary endpoint is the proportion of nights (23.00-07.00) with at least one biochemical hypoglycemic event (P-glucose <3.3 mmol/L, corresponding to B-glucose<3.0 mmol/L) captured by Continuous Glucose Monitoring System (CGMS) during two periods (each consisting of three consecutive nights) during week 4 and 8 of treatment with MM005-Granulae or placebo. | — |
Countries
Sweden
Outcome results
None listed