Sarnblad 2003.
| Methods | DESIGN: Randomized double blind placebo controlled trial COUNTRY: Sweden DURATION OF INTERVENTION: 3 months DURATION OF FOLLOW‐UP: 3 months RUN‐IN PERIOD: 1 month LANGUAGE OF PUBLICATION: English | |
| Participants | WHO PARTCIPATED: N= 30 adolescents SEX: 21 females, 9 males DISEASE: poorly controlled type 1 diabetes INCLUSION CRITERIA: Girls: 14‐20 years, Boys: 16‐20 years, HB A1c above 8%, daily dosage of insulin > 0.9 U/kg EXCLUSION CRITERIA: other diseases, other medications, persistent nephropathy DIAGNOSTIC CRITERIA: typical diabetes symptoms and ketosis at onset, required insulin treatment from onset of diabetes, late stages of pubertal development (Tanner 4‐5) SUBGROUPS: none CO‐MORBIDITIES: none CO‐MEDICATIONS: none | |
| Interventions | NUMBER OF STUDY CENTRES: five departments of Pediatrics COUNTRY/ LOCATION: central Sweden ( Eskilstuna, Falun, Karlstad, Vasteras and Orebro) SETTING: Pediatric outpatient departments INTERVENTION : N= 16 patients SEX: 11 females, 5 males DESCRIPTION: s.c. insulin and oral metformin 500 mg/d for 1 week, followed by 500 mg twice daily for 3 weeks, then 1000 mg twice daily for 8 weeks CONTROL: N= 14 patients, SEX: 10 females, 4 males, DESCRIPTION: s.c. insulin and placebo TREATMENT BEFORE STUDY: s.c. insulin TITRATION PERIOD: none | |
| Outcomes | 1. Glycemic control: HBA1c and blood glucose
2. Side effects: hypoglycaemia, GIT (discomfort, vomiting, abdominal pain), lactic acidosis, ketoacidosis
3. Quality of life: not reported
4. Insulin dose: daily insulin dose/Kg
5. Weight: BMI, body weight
6. Serum lipids: serum triglycerides and cholesterol
7. Insulin sensitivity (by euglycaemic hyperinsulinaemic clamp)
8. Cost: not reported
9. Compliance : <10% of total doses missed
10. Mortality: not reported
11. Morbidity: not reported SAFETY ASSESSMENTS: 1. renal functions 2. hepatic functions (alanine aminotransferase and aspartate aminotransferase) 3. complete blood count 4. lactate 5. mild symptomatic hypoglycemia 6. severe hypoglycemic episodes |
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| Notes | Sponsor: Drugs and placebo were provided by Merck AB, Pharma division Authors contacted: Study retreived:Medline | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | Unclear risk | B ‐ Unclear |