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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.

Efficacy and Safety of Dapagliflozin in Combination with Metformin in Type 2 Diabetes Patients

Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks

Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks

Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks

Research Site

A 52-Week International, Multi-centre, Randomised, Parallel-group, Double-blind, Active-controlled, Phase III study with a 156-Week Extension Period to Evaluate the Efficacy and Safety of Dapagliflozin in Combination with Metformin compared with Sulphonylurea in Combination with Metformin in Adult Patients with Type 2 Diabetes who have Inadequate Glycaemic Control on Metformin Therapy Alone.

To examine dapagliflozin plus metformin is non-inferior to glipizide plus metformin with regard to the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.  Primary endpoint significant non-inferior if upper limit of 95% CI is <0.35%. Analysis of continuous outcome based on ANCOVA model with treatment group as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from glip.+met.:  0.00 (-0.11, 0.11), p<0.0001.

Age Continuous

Gender, Male/Female

Race, Customized

Study Specific Characteristic

HbA1c

Full Analysis Set defined as all randomized participants (as randomized) who received at least one dose of double-blind study medication, who have a non-missing baseline value and at least one post-baseline efficacy value for at least one efficacy variable during double-blind treatment period. 

For participants who did not complete 52 weeks LOCF (last observation carried forward) was used.

To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on the absolute change from baseline in HbA1c level after 52 weeks double-blind treatment in patients with type 2 diabetes who have inadequate glycaemic control on 1500 mg/day or higher doses of metformin therapy alone.

The null hypothesis is given as H0: mean(treat) minus mean(reference) >= delta versus the alternative HA: mean(treat) minus mean(reference) < delta (with alpha = 0.025, one-sided)

Full Analysis Set, participants with non-missing baseline and Week 52 (LOCF) values

Adjusted mean change in HbA1c levels

To assess the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight after 52 weeks double-blind treatment.

H0: mean(treat) minus mean(reference) = 0 versus the alternative HA: mean(treat) minus mean(reference) =/= 0

Adjusted mean change in body weight

To assess the effect of dapagliflozin plus metformin treatment compared to glipizide plus metformin on the occurrence of hypoglycemic events. Least Squares Mean represents the percent of participants adjusted for HbA1c baseline value.

H0: proportion(treat) minus proportion(reference) = 0 versus the alternative HA: proportion(treat) minus proportion(reference) =/= 0

Proportion of participants with at least one episode of hypoglycemia

To evaluate the effect of dapagliflozin plus metformin compared to glipizide plus metformin on body weight assessed by a reduction after 52 weeks of at least 5% compared to baseline. Least Squares Mean represents the percent of participants adjusted for baseline value.

Proportion of participants with body weight reduction of at least 5%

Overall Study

For participants with a metformin dose of less than 1500 mg/day, a change in metformin dose in the past 8 weeks or on an Oral Anti-Diabetic (OAD), an 8-week metformin-only dose stabilisation period occurred.    A 2-week placebo lead in period occurred after the dose stabilisation period or after enrolment if dose stabilisation period was skipped.

Eva Johnsson

To show that dapagliflozin plus metformin reduces body weight compared to glipizide plus metformin after 52 weeks double-blind treatment. Secondary endpoints are tested following sequential testing procedure at  alpha=0.05 (two-sided). Analysis of continuous outcome based on ANCOVA model with treatment group as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from glip.+met.:  -4.65 (-5.14, -4.17), p<0.0001.

To show that dapagliflozin plus metformin treatment leads to fewer participants with hypoglycemic events compared to glipizide plus metformin. Secondary endpoints are tested following sequential testing procedure at  alpha=0.05 (two-sided). Logistic regression analysis of responses based on methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline value. Outcome measure type Least Squares Mean represents the adjusted percent of participants with at least one hypoglycemic event during 52-week double-blind treatment. Difference from glip.+met.:  -37.2 (-42.3, -32.2), p<0.0001.

To show that a higher percentage of participants treated with dapagliflozin plus metformin reduce their baseline body weight for at least 5% compared to participants treated with glipizide plus metformin after 52 weeks of treatment. Secondary endpoints are tested following sequential testing procedure at  alpha=0.05 (two-sided). Logistic regression analysis of responses based on methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline value. Outcome measure type Least Squares Mean represents the adjusted percent of participants with reduction of >= 5% compared to baseline. Difference from glip.+met.:  30.8 (26.0, 35.7), p<0.0001.

Arms	Assigned Interventions
Experimental: 1 dapagliflozin plus metformin	Drug: dapagliflozin Tablet oral 2.5, 5, or 10 mg total daily dose once daily 208 weeks Drug: metformin hydrochloride Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks Other Name: Glucophage
Active Comparator: 2 glipizide plus metformin	Drug: glipizide Capsule oral 5, 10, or 20 mg total daily dose once or split/twice daily 208 weeks Other Name: Glucotrol Drug: metformin hydrochloride Tablet oral 1500, 2000, or 2500 mg total daily dose split/twice daily 218 weeks Other Name: Glucophage

Efficacy and Safety of Dapagliflozin in Combination with Metformin in Type 2 Diabetes Patients

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Documents available

CSR-D1690C00004.pdf

Trial Results Summaries

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