Skip to main content
. 2017 Jun 8;2017(6):CD010137. doi: 10.1002/14651858.CD010137.pub2

STENO‐2 Study 1999.

Methods

  • Study design: parallel RCT

  • Study duration (recruitment): 1992 to 1993

  • Follow‐up period: 94 months
Participants

  • Country: Denmark

  • Setting: single centre

  • Patients with type 2 diabetes and CKD Stage 1; persistent microalbuminuria

  • Number: treatment group (80); control group (80)

  • Mean age ± SD (years): treatment group (54.9 ± 7.2); control group (55.2 ± 7.2)

  • Sex (M/F): treatment group (63/17); control group (56/24)

  • Exclusion criteria: age > 65 or < 40 years; a stimulated serum C peptide concentration < 600 pmol/L 6 min after intravenous injection of 1 mg glucagon; pancreatic insufficiency or diabetes secondary to pancreatitis; alcohol abuse; non‐DKD; malignancy; life‐threatening disease with death probable within 4 years
Interventions Treatment group

  • Intensive treatment


Control group

  • Conventional treatment
Outcomes

  • Composite of death from cardiovascular causes, nonfatal myocardial infarction, coronary‐artery bypass grafting, percutaneous coronary intervention, nonfatal stroke, amputation as a result of ischaemia, or vascular surgery for peripheral atherosclerotic artery disease

  • incidence of DKD

  • Development or progression of diabetic retinopathy or neuropathy
Notes

  • Funding source: Merck, Bristol‐Myers Squibb, Pfizer, and Sanofi
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomisation (groups of 4 with 2 in each treatment arm and thus allowed a
 maximum difference of two patients per group per stratum)
Allocation concealment (selection bias) Low risk Performed with the use of sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk All endpoints specified in the protocol were adjudicated by an independent committee whose members were unaware of the patients’ treatment assignments
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 3/160 lost to follow‐up (2%)
Selective reporting (reporting bias) Low risk Important patient‐level outcomes provided
Other bias High risk Data not independent of sponsor