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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 in addition to metformin decreases body weight and if so, how it compares with metformin alone.

Evaluation of the Effect of Dapagliflozin in Combination with Metformin on Body Weight in Subjects with Type 2 Diabetes

Tablet oral 10 mg total daily dose once daily 102 weeks

Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks

Tablet oral 100 mg total daily dose once daily rescue medication

Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks

D1690C00012 Clinical Study Report Synopsis

Research Site

A 24-week,Multi-centre,Int.,Double-blind,Rand.,Parallel-group,Plac.-controlled,Phase III Study with a 78-week Ext.Per. to Evaluate the Effect of Dapagliflozin in Combination with Metformin on Body Weight in Subjects with Type2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment. Primary endpoint tested at alpha=0.05. Analysis of continuous outcome based on ANCOVA model with treatment group and stratum as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: -2.08  (-2.84,  -1.31), p<0.0001.

Age Continuous

Gender, Male/Female

Race, Customized

Body Weight

Study Specific Characteristic

Body Mass Index

Glycosylated hemoglobin A1c (HbA1c)

Fasting Plasma Glucose

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 24 weeks, last observation carried forward (LOCF) was used.

To evaluate the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin on total body weight after 24 weeks of oral administration of double-blind treatment.

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

Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values

Adjusted mean change in total body weight

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference.

Adjusted mean change in waist circumference

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry. 

Adjusted mean change in body fat mass

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. Least Squares Mean represents the percent of participants adjusted for body weight baseline value.

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

Proportion of participants with body weight decrease ≥5%

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at lumbar spine (L1-4) as measured by Dual Energy X-ray Absorptiometry.

Safety Analysis Set (all participants who received at least one dose of double-blind study medication)

Adjusted percent change in bone mineral density (BMD) at lumbar spine (L1-4)

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at femoral neck as measured by Dual Energy X-ray Absorptiometry.

Adjusted percent change in bone mineral density (BMD) at femoral neck

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 102 weeks of double-blind treatment on Bone Mineral Density at total hip as measured by Dual Energy X-ray Absorptiometry.

Adjusted percent change in bone mineral density (BMD) at total hip

Overall Study

During a placebo lead-in period, participants were counselled on dietary and life-style modifications. The metformin dose was adjusted to open label 1500 mg/day, 2000 mg/day or 2500 mg/day. Neither gender should exceed 60% of the total number of randomized participants.

Eva Johnsson

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on waist circumference. If p-value for primary endpoint significant, results of key secondary endpoints are interpreted using Hochberg's method. Analysis of continuous outcome based on ANCOVA model with treatment group and stratum as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: -1.52  (-2.74,  -0.31), p=0.0143.

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on total body fat mass measured by dual energy X-ray absorptiometry. If p-value for primary endpoint significant, results of key secondary endpoints are interpreted using Hochberg's method. Analysis of continuous outcome based on ANCOVA model with treatment group and stratum as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: -1.48  (-2.22,  -0.74), p=0.0001.

To assess the effect of dapagliflozin 10 mg daily in combination with metformin compared to placebo in combination with metformin after 24 weeks of double-blind treatment on body weight decrease ≥5%. If p-value for primary endpoint significant, results of key secondary endpoints are interpreted using Hochberg's method. Logistic regression analysis of responses based on methodology of Zhang, Tsiatis & Davidian and Davidian, Tsiatis, Zhang & Lu, with adjustment for baseline value and stratum. Outcome measure type Least Squares Mean represents adjusted percent. Difference from placebo: 26.3  (15.9,  36.7), p<0.0001.

Arms	Assigned Interventions
Experimental: A Dapagliflozin 10 mg plus Metformin	Drug: Dapagliflozin Tablet oral 10 mg total daily dose once daily 102 weeks Drug: Metformin Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks Drug: Sitagliptin Tablet oral 100 mg total daily dose once daily rescue medication
Placebo Comparator: B Placebo plus Metformin	Drug: Metformin Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks Drug: Sitagliptin Tablet oral 100 mg total daily dose once daily rescue medication Drug: Placebo Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks

Evaluation of the Effect of Dapagliflozin in Combination with Metformin on Body Weight in Subjects with Type 2 Diabetes

Official Title

Medical condition

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Healthy volunteers

Study drug

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Verification:

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Documents available

D1690C00012 Clinical Study Report Synopsis

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator