Abstract | BACKGROUND: OBJECTIVE: DESIGN: Open-label, randomized trial. SETTING: Teaching hospital (Azienda Ospedaliera Universitaria, Second University of Naples), Naples, Italy. PATIENTS: 116 adults receiving stable doses of metformin plus sulfonylurea for longer than 90 days with hemoglobin A(1c) (HbA(1c)) levels of 7.5% to 10% and fasting plasma glucose levels of 6.7 mmol/L or greater (> or =120 mg/dL). INTERVENTION: 10 IU of NPL insulin or insulin glargine injected subcutaneously at bedtime with weekly dose titrations to target fasting glucose levels less than 5.6 mmol/L (<100 mg/dL) in addition to stable oral regimens. Patients receiving nighttime sulfonylurea before the study were switched to metformin. MEASUREMENTS: The primary outcome was change in HbA(1c) levels from baseline to week 36. Secondary outcomes were HbA(1c) levels less than 7%, self-reported hypoglycemic episodes, insulin dose, self-monitored glucose level, and body weight. Twenty patients in each group had continuous glucose monitoring for 3 consecutive days before adding insulin and at week 36. RESULTS: Improvement in HbA(1c) levels was similar in both groups (1.83% and 1.89% for NPL and glargine, respectively). The difference between the groups was 0.06 percentage point (95% CI, -0.1 to 0.15 percentage points). Secondary outcomes did not differ between groups. Hemoglobin A(1c) levels less than 7% occurred in 62% of patients receiving NPL and 64% of patients receiving glargine (difference, 2.0 percentage points [CI, -1.1 to 5.0 percentage points]). Fasting plasma glucose levels less than 5.6 mmol/L (<100 mg/dL) occurred in 40% of patients receiving NPL and 41% of patients receiving glargine (difference, 1.0 percentage point [CI, -0.9 to 3.0 percentage points]). Any hypoglycemic event occurred in 74% of patients receiving NPL and 67% of patients receiving glargine (difference, 7 percentage points [CI, -5 to 13 percentage points]). Continuous glucose level monitoring in the patients who had this measurement did not differ statistically. LIMITATION: The study was not blinded, had limited power to detect differences in hypoglycemic events, and did not obtain continuous glucose level monitoring for all patients. CONCLUSION:
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Authors | Katherine Esposito, Miryam Ciotola, Maria Ida Maiorino, Roberto Gualdiero, Bruno Schisano, Antonio Ceriello, Flora Beneduce, Giovanni Feola, Dario Giugliano |
Journal | Annals of internal medicine
(Ann Intern Med)
Vol. 149
Issue 8
Pg. 531-9
(Oct 21 2008)
ISSN: 1539-3704 [Electronic] United States |
PMID | 18936501
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Blood Glucose
- Glycated Hemoglobin A
- Hypoglycemic Agents
- Insulin
- Insulin, Long-Acting
- Protamines
- Sulfonylurea Compounds
- neutral protamine lispro insulin
- Insulin Glargine
- Metformin
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Topics |
- Administration, Oral
- Adult
- Aged
- Blood Glucose
(metabolism)
- Diabetes Mellitus, Type 2
(blood, drug therapy)
- Drug Therapy, Combination
- Female
- Glycated Hemoglobin
(metabolism)
- Humans
- Hypoglycemia
(chemically induced)
- Hypoglycemic Agents
(administration & dosage, adverse effects)
- Injections, Subcutaneous
- Insulin
(administration & dosage, adverse effects, analogs & derivatives)
- Insulin Glargine
- Insulin, Long-Acting
- Male
- Metformin
(administration & dosage, adverse effects)
- Middle Aged
- Protamines
(administration & dosage, adverse effects)
- Sulfonylurea Compounds
(administration & dosage, adverse effects)
- Weight Gain
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