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Posted by on Jun 6, 2015 in Diabetes mellitus | 0 comments

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.

Some background

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 medicationsMetformin (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 metforminDulaglutide 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

Date :

Apr 23, 2015

Original Title :

Safety and Efficacy of Once Weekly Dulaglutide vs Sitagliptin After Two Years in Metformin-treated Patients with Type 2 Diabetes (AWARD-5): A Randomised, Phase 3 Study.

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