The Treat-to-Target Trial: Randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients

Emerging Treatments and Technologies

The Treat-to-Target Trial

Address correspondence and reprint requests to Matthew C. Riddle, MD, Oregon Health and Science University, Section of Diabetes L-345, 3181 S.W. Sam Jackson, Portland, OR 97201. E-mail: riddlem{at}ohsu.edu

Diabetes Care 2003 Nov; 26(11): 3080-3086. https://doi.org/10.2337/diacare.26.11.3080

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Figure 1—
FPG (A) and HbA_1c (B) during the study. Values in both figures are means; error bars indicate SE.
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Figure 2—
Cumulative number of hypoglycemia events. Events with plasma-referenced glucose (PG) ≤72 mg/dl (4.0 mmol/l) (A) and with PG ≤56 mg/dl (3.1 mmol/l) (B) are depicted.
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Figure 3—
Distribution of hypoglycemia by time of day. A: The proportion of patients experiencing at least one episode of hypoglycemia documented with plasma-referenced glucose ≤72 mg/dl (4.0 mmol/l). B: The hourly hypoglycemia rates, expressed as events per patient-year at the same plasma-referenced glucose cutoff.

Table 1—

Forced weekly insulin titration schedule

Start with 10 IU/day bedtime basal insulin and adjust weekly
Mean of self-monitored FPG values from preceding 2 days	Increase of insulin dosage (IU/day)
≥180 mg/dl (10 mmol/l)	8
140–180 mg/dl (7.8–10.0 mmol/l)	6
120–140 mg/dl (6.7–7.8 mmol/l)	4
100–120 mg/dl (5.6–6.7 mmol/l)	2

The treat-to-target FPG was ≤100 mg/dl. Exceptions to this algorithm were 1) no increase in dosage if plasma-referenced glucose <72 mg/dl was documented at any time in the preceding week, and 2) in addition to no increase, small insulin dose decreases (2–4 IU/day per adjustment) were allowed if severe hypoglycemia (requiring assistance) or plasma-referenced glucose <56 mg/dl were documented in the preceding week.

Table 2—

Baseline characteristics of subjects in the study