In a nutshell
This study evaluated the long-term safety and effectiveness of dulaglutide (Trulicity) compared to sitagliptin (Januvia) in the treatment of type 2 diabetes.
Type 2 diabetes is a progressive disease. While it initially can be treated through diet and lifestyle changes, patients will eventually need to add glucose (sugar)-lowering medications. Metformin (Glucophage), a glucose-lowering drug is the standard treatment for type 2 diabetes. However, if it does not control the blood sugar level adequately, other medications can be added. Sitagliptin (Januvia) increases the amount of insulin (the hormone needed to break down glucose) produced by the body, and can be added to metformin.
Dulaglutide is a newer once-a-week injectable treatment that can be used in combination with metformin. Dulaglutide also increases insulin production, as well as delaying how quickly the stomach empties food following a meal. Dulaglutide has been found to be safe and effective at reducing blood glucose levels and body weight in the short term (up to 1 year). However, the long term safety and effectiveness of this drug needs to be evaluated.
Methods & findings
The current study aimed to compare the safety and effectiveness of dulaglutide to that of sitagliptin in type 2 diabetes patients whose blood glucose was not controlled with metformin. This study included 657 patients, of whom, 192 received 1.5 mg dulaglutide (Group 1), 184 received 0.75 mg of dulaglutide (Group 2), 186 received sitagliptin (Group 3) and 95 received placebo. Patients were treated for 104 weeks. The change in HbA1c (average blood glucose over 3 months), body weight, and insulin production was compared from the start of the study to the end of 104 weeks. The number of adverse (negative) events, including hypoglycemia (abnormally low blood glucose), was measured for each patient.
HbA1c decreased by 0.99% in Group 1 and by 0.71% in Group 2, significantly more than the 0.32% decrease seen in Group 3. The number of patients who achieved the HbA1c target level of < 7.0% was significantly higher in Groups 1 (54%) and 2 (45%) than in Group 3 (31%). Patients in Group 1 lost an average of 2.88 kg and patients in Group 2 lost 2.39 kg. Patients in Group 3 lost an average of 1.75 kg. Insulin production was also significantly higher in patients in Groups 1 and 2 than in Group 3.
Nausea was experienced more often by Group 1 (17%) and Group 2 (15%), compared to patients in Group 3 (7%). Similarly, patients in Group 1 (16%) and Group 2 (12%) had diarrhea more often than patients in Group 3 (6%). These events occurred most often during the first 2 weeks of treatment (9 to 15%) and declined steadily in the following weeks. Hypoglycemia was reported by 12.8% of Group 1, 8.6% of Group 2, and 8.6% of Group 3.
The bottom line
This study concluded that long-term treatment with dulaglutide safely and effectively decreased both blood glucose levels and weight compared to sitagliptin in type 2 diabetes patients.
The fine print
This study was funded by Eli Lilly, the manufacturers of dulaglutide.
Published By :
Diabetes, Obesity and Metabolism
Apr 23, 2015
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