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

Metcon Medicin AB0 个研究点目标入组 160 人开始时间: 2004年12月3日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

•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)

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