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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 insulin is effective and safe in treating patients with type 2 diabetes when compared to placebo (identical looking inactive treatment) in addition to insulin

Efficacy and safety of dapagliflozin, added to therapy of patients with Type 2 Diabetes with inadequate glycemic control on insulin

tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)

Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)

Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)

tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)

tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg

Research Site

A 24-week international, randomized, parallel-group, double-blind, placebo-controlled Phase III study with a 80-week extension period to evaluate the efficacy and safety of dapagliflozin therapy when added to the therapy of patients with type 2 diabetes with inadequate glycaemic control on insulin

To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in subjects with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration. Primary endpoint is tested at alpha=0.019 applying the Dunnett's adjustment. Analysis of continuous outcome based on ANCOVA model with treatment group and stratum (other anti-diabetic med use) as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: 2.5mg: -0.45 (-0.59,-0.31), p<0.0001; 5mg: -0.52 (-0.66,-0.38), p<0.0001; 10mg: -0.60 (-0.74,-0.45), p<.0001.

Age Continuous

Gender, Male/Female

Race, Customized

Body Mass Index

Study Specific Characteristic

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 LOCF (last observation carried forward) was used. Only values prior to insulin up-titration were used for outcome measures except for mean daily insulin dose which was evaluated regardless of.

To assess the efficacy of 2.5 mg, 5 mg and 10 mg dapagliflozin compared to placebo as add-on therapy to insulin in improving glycaemic control in participants with type 2 diabetes who have inadequate glycaemic control on ≥ 30 IU injectable insulin daily for at least 8 weeks prior to enrolment, as determined by the change in HbA1c levels from baseline to Week 24, excluding data after insulin up-titration.

The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.019 applying Dunnett's adjustment, two-sided)

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

Adjusted mean change in HbA1c levels

To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration.

The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0

Adjusted mean change in body weight

To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration.

Adjusted mean change in calculated mean daily Insulin dose

To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction >= 10%) as compared to placebo added to insulin treatment.

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

Proportion of participants with calculated mean daily insulin dose reduction

To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration.

Adjusted mean change in Fasting Plasma Glucose (FPG)

Participants with lack of glycemic control or insulin up-titration for failing to achieve pre-specified glycemic targets

Proportion of participants with Lack of Glycemic Control

Overall Study

For two weeks prior to randomization, particpants recorded their daily self monitored plasma glucose and insulin use. At randomization, qualified participants were stratified according to their use of other anti-diabetic (OAD) medication or not. No more than 60% of enrolled participants were to take insulin plus OADs.

Eva Johnsson

To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing body weight or causing less weight gain as compared to placebo added to insulin treatment after 24 weeks of treatment (LOCF), excluding data after insulin up-titration. 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 and stratum (other anti-diabetic med use) as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: 2.5mg -1.00 (-1.50,-0.49), p=0.0001; 5mg -1.00 (-1.50,-0.50), p<0.0001; 10mg -1.68 (-2.19,-1.18), p<0.0001.

To examine whether treatment with dapagliflozin in combination with insulin leads to a lower absolute calculated mean daily insulin dose as compared to placebo added to insulin treatment alone, from baseline to week 24, including data after insulin up-titration. 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 and stratum (other anti-diabetic med use) as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from place: 2.5mg: -6.87  (-9.46,-4.28), p<0.0001; 5mg: -5.69 (-8.25,-3.13), p<0.0001; 10mg: -6.23 (-8.84,-3.63), p<.0001.

To examine whether treatment with dapagliflozin in combination with insulin leads to higher percentage of participants with calculated mean daily insulin dose reduction from baseline to week 24 (i.e. reduction >= 10%) as compared to placebo added to insulin 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 and stratum (other anti-diabetic med use). Outcome measure type Least Squares Mean represents adjusted percent. Difference from placebo: 2.5mg: 7.2% (0.2,14.1), p=0.0427; 5mg: 5.8% (-0.9, 12.5), p=0.0903; 10mg: 8.7% (1.6, 15.8);  p=0.0166.

To examine whether treatment with dapagliflozin in combination with insulin is superior in reducing Fasting Plasma Glucose (FPG) as compared to placebo added to insulin treatment after 24 weeks of treatment, excluding data after insulin up-titration. 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 and stratum (other anti-diabetic med use) as effect and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: 2.5mg: -15.8 (-25.0, -6.6), p=0.0008; 5mg: -22.1 (-31.2,-13.1), p<0.0001; 10mg: -25.0 (-34.3,-15.8), p<0.0001. 5mg not statistically significant due to testing procedures.

Arms	Assigned Interventions
Experimental: 1 2.5mg	Drug: Dapagliflozin tablet oral 2.5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I) Drug: Dapagliflozin tablet oral 2.5 total daily dose once daily 56 weeks (= 56 week study extension period II)
Experimental: 2 5mg	Drug: Dapagliflozin Tablet oral 5 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I)
Experimental: 3 10mg	Drug: Dapagliflozin Tablet oral 10 mg total daily dose once daily 48 weeks (= 24 week randomised treatment period + 24 week study extension period I) Drug: Dapagliflozin tablet oral 10 mg total daily dose once daily 56 weeks (= 56 week study extension period II)patients that have been treated with 5 mg during the 24 week randomised treatment period and extension I period will during extension II period switched to 10 mg
Placebo Comparator: 4	Drug: Placebo Placebo

Efficacy and safety of dapagliflozin, added to therapy of patients with Type 2 Diabetes with inadequate glycemic control on insulin

Official Title

Medical condition

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Documents available

CSR-D1690C00006.pdf

D1690C00006 Clinical Study Protocol

Trial Results Summaries

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Principal Investigator