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Dapagliflozin Improves Glycemic Control without Weight Gain
Diabetes medications are insulin-dependent, and the efficacy of these drugs diminishes when the function of pancreatic islet ß-cells declines during the progression of diabetes. Some diabetes drugs can cause weight gain in patients, which further compromises insulin resistance.
A recent study examined the sodium glucose cotransporter 2, dapagliflozin, to determine if using this medication as an add-on to already established treatment regimens would eliminate the risk of weight gain [BMJ Open. 2014;4:e004619]. Previous studies on dapagliflozin have found that it is insulin-independent, enhancing glycemic control without adverse effects related to body weight, blood pressure, and lipids.
This systematic review and meta-analysis of randomized, controlled trials pulled relevant studies using keywords from PubMed, Cochrane Library, EMBASE, ClinicalTrials.gov, Google Scholar, and Google. Randomized, controlled trials were included if the met the following criteria: (1) the follow-up duration was longer than 8 weeks; (2) study participants were ≥18 years of age; (3) dapagliflozin was used as an add-on therapy to conventional diabetes medications; (4) control groups received placebo combined with another conventional diabetes medication; and (5) study outcomes included glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and body weight. A total of 12 studies met the inclusion criteria and were included in the analysis. These studies used intervention variations of 2.5 mg, 5 mg, and 10 mg of add-on dapagliflozin.
Twelve studies with 3986 participants were included in the specific analysis on effect of HbA1c levels. There were 1996 participants in the intervention groups (10 mg dapagliflozin combined with 5 diabetes medications—metformin, insulin, glimepiride, pioglitazone, and metformin/sitagliptin) and 1990 participants in the control groups (placebo combined with corresponding diabetes drug). The analysis found that HbA1c levels decreased after supplementation of dapagliflozin, with a mean difference of -0.52% (95% confidence interval [CI], -0.6–-0.45; P<.001).
Twelve studies with 3620 patients reported the effect on FPG. The intervention group (n=1817) received 10 mg of dapagliflozin combined with 1 of the 5 types of drugs mentioned previously and the control group (n=1803) received placebo combined with the corresponding drugs. Follow-up ranged from 12 to 104 weeks. All of the studies showed decreases in FPG after dapagliflozin add-on. The mean difference between the intervention and control groups was -1.13 mmol/L (95% CI, -1.33–-0.93; P<.001).
An additional twelve studies with a total of 4008 participants reported on the effect dapagliflozin has on body weight changes. The intervention groups (n=2005) received 10 mg dapagliflozin combined with 1 of the 5 drug types mentioned previously and the control group (n=2003) received placebo combined with the corresponding drugs. Follow-up durations ranged from 12 to 104 weeks. The studies showed a decrease in body weight after dapagliflozin was initiated, with decreases ranging from -3.33 kg to -1.54 kg. The overall mean difference between the intervention and control groups was -2.1 kg (95% CI, -2.33–-1.88; P<.001).
The study’s authors noted limitations. Some of the analyses only have short follow-up periods, and only a 10 mg dose of dapagliflozin was examined.
The study’s authors concluded that dapagliflozin as an add-on to conventional diabetes medication improved glycemic control and reduced weight gain in type 2 diabetes.
