Efficacy of MM005-Granulae as prophylaxis for nocturnal hypoglycemia in insulin treated Type 1 diabetic subjects. A double-blind, randomized, placebo-controlled phase II multi-center study in three parallel arms. - GLU-005

• Conditions: Diabetes type I; MedDRA version: 6,1Level: LLTClassification code 10045228

• Registration Number: EUCTR2004-002070-36-SE
• Lead Sponsor: Metcon Medicin AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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 < 3.3 mmol/L, corresponding to blood glucose <3.0 mmol/L
5. Duration of diabetes =3 years
6. BMI = 19 to < 30 (kg/m2)
7. HbA1c = 8.5 % (based on sample taken at enrollment visit)
8. C-peptide < 0.17 nmol/L (based on sample taken at enrollment visit) unless the diagnosis has been similarly confirmed and documented before
9. Compliance of at least 65%* during run-in period(*depending on length of the run-in period, this means medication taken for at least 4 out of 5 days, 4 out of 6 days or 5 out of 7 days)

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified