Adding Once-Daily Lixisenatide for Type 2Diabetes Inadequately Controlled With

Newly Initiated and ContinuouslyTitrated Basal Insulin Glargine

A 24-Week, Randomized, Placebo-Controlled Study (GetGoal-Duo 1)

Featured Article:

Matthew C. Riddle, M.D., Thomas Forst, M.D., Ronnie Aronson, M.D., F.R.C.P.C., F.A.C.E., Leobardo Sauque-Reyna, M.D., Elisabeth Souhami, M.D., Louise

Silvestre, M.D., Lin Ping, M.D., Julio Rosenstock, M.D.

Diabetes Care Volume 36: 2497-2503

September, 2013

STUDY OBJECTIVE 

• When oral therapy for type 2 diabetes is ineffective, adding basal insulin improves glycemic control

• However, when glycated hemoglobin (HbA1c) remains elevated because of postprandial hyperglycemia, the next therapeutic step is controversial

• We examined the efficacy and safety of lixisenatide in patients with HbA1c still elevated after initiation of insulin glargine

Riddle M. C. et al. Diabetes Care 2013;36:2497-2503

STUDY DESIGN AND METHODS

• This double-blind, parallel-group trial enrolled patients with HbA1c of 7–10% despite oral therapy

• Insulin glargine was added and systematically titrated during a 12-week run-in

• After the run-in period, candidates with fasting glucose ≤7.8 mmol/L and HbA1c 7–9% were randomized to 20 g lixisenatide or placebo for 24 weeks while insulin titration continued

• Primary end point was HbA1c change after randomization

Riddle M. C. et al. Diabetes Care 2013;36:2497-2503

RESULTS

• Randomized population had mean diabetes duration of 9.2 years, BMI 31.8 kg/m2, and daily glargine dosage of 44 units

• HbA1c had decreased during run-in from 8.6 to 7.6%

• Adding lixisenatide further reduced HbA1c by 0.71 vs. 0.40% with placebo

• More participants attained HbA1c <7% with lixisenatide

• Lixisenatide reduced plasma glucose 2 h after a standardized breakfast and had a favorable effect on body weight

• Nausea, vomiting, and symptomatic hypoglycemia <3.3 mmol/L were more common with lixisenatide

Riddle M. C. et al. Diabetes Care 2013;36:2497-2503

Riddle M. C. et al. Diabetes Care 2013;36:2497-2503

Riddle M. C. et al. Diabetes Care 2013;36:2497-2503

Riddle M. C. et al. Diabetes Care 2013;36:2497-2503

CONCLUSIONS

• Adding lixisenatide to insulin glargine improved overall and postprandial hyperglycemia

• Lixisenatide should be considered as an alternative to prandial insulin for patients not reaching HbA1c goals with recently initiated basal insulin

Riddle M. C. et al. Diabetes Care 2013;36:2497-2503

Riddle M. C. et al. Diabetes Care 2013;36:2497-2503

Riddle M. C. et al. Diabetes Care 2013;36:2497-2503