TABLE 2.

Hypoglycemia in Studies of First-Generation Basal Insulin Analogs in Older Patients With Type 2 Diabetes

ReferenceType of StudyAge-Group, yearsnGlycemic TargetHypoglycemia, %*
OverallNocturnalSevere
Insulin glargine 100 units/mL
Pandya et al. (32)Pooled analysis of 24-week data from nine prospective, open-label, multicenter, phase 3/4 clinical trials˂652,263FPG ≤100 mg/dL23.78.70.8,§
≥65675FPG ≤100 mg/dL27.37.22.2,§
Owens et al. (33)Pooled analysis of 16 prospective, randomized, treat-to-target clinical trials˂652,411FPG ˂100 mg/dL47.6||19.9||2.1
≥65777FPG ˂100 mg/dL47.0||17.8||2.1
Chien et al. (34)Retrospective, registry analysis˂6540No set goal††15.0NR2.5
≥6532No set goal††9.4NR0
Insulin detemir
Bhargava et al. (37)Post-hoc subanalysis of a randomized, open-label, phase 4 trial˂651,915No set goal††NR4.4#0.3 (day),
0.3 (nocturnal)
≥65897No set goal††NR5.3#0.5 (day),
0.4 (nocturnal)
Karnieli et al. (38)Subanalysis of an observational study˂7514,873No set goal††NRNR0.005 per patient-year
≥752,398No set goal††NRNR0.007 per patient-year
Malek et al. (39)Subanalysis of observational study˃40–6510,967No set goal††4.7#1.7#0**
˃652,807A1C ˂7.5%6.6#2.3#0**
  • NR, not reported.

  • * No significant difference reported between age-groups within treatment groups unless otherwise stated.

  • Blood glucose ˂50 mg/dL.

  • Events requiring assistance and blood glucose ˂36 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration.

  • § P = 0.023. ||Blood glucose ≤70 mg/dL.

  • Events requiring assistance of another person.

  • †† Changes in A1C and/or FPG were measured in these studies, but no analysis was performed against a pre-defined target level.

  • # Symptoms of hypoglycemia that resolved with oral carbohydrate intake, glucagon, or intravenous glucose, or any symptomatic or asymptomatic blood glucose ˂56 mg/dL.

  • ** Severe central nervous system symptoms consistent with hypoglycemia, during which the patient was unable to self-treat and had one of the following characteristics: plasma glucose ˂56 mg/dL or reversal of symptoms after either food intake, glucagon, or intravenous glucose administration.