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CompletedNCT00680745Updated Oct 14, 2013Results posted

Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients

A Phase 3 interventional study of dapagliflozin and Glimepiride in Type 2 Diabetes, sponsored by AstraZeneca. Completed at 66 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-14.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
597
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is being carried out to see if dapagliflozin in addition to glimepiride (sulphonylurea) is effective and safe in treating patients with type 2 diabetes when compared to glimepiride alone.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Dapagliflozin
  • efficacy
  • safety
  • sulphonylurea
  • Type 2 diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 597 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 Diabetes
  • Treatment with a stable sulphonylurea monotherapy dose that is at least half the maximal recommended dose for a minimum of 8 weeks prior to study
  • Inadequate glycaemic control, defined as A1C ≥ 7.0 % and ≤ 10%

Exclusion criteria

Exclusion Criteria:

  • Type 1 Diabetes
  • Hepatic (liver) impairment
  • Renal (kidney) failure or dysfunction
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
597 participants (actual)

Study arms

  • Experimental
    1

    dapagliflozin 2.5mg + Glimepiride

    Drug: dapagliflozin · Drug: Glimepiride · Drug: metformin hydrochloride · Drug: pioglitazone hydrochloride · Drug: Rosiglitazone

  • Experimental
    2

    dapagliflozin 5mg + Glimepiride

    Drug: dapagliflozin · Drug: Glimepiride · Drug: metformin hydrochloride · Drug: pioglitazone hydrochloride · Drug: Rosiglitazone

  • Experimental
    3

    dapagliflozin 10mg + Glimepiride

    Drug: dapagliflozin · Drug: Glimepiride · Drug: metformin hydrochloride · Drug: pioglitazone hydrochloride · Drug: Rosiglitazone

  • Placebo comparator
    4

    Placebo + Glimepiride

    Drug: Glimepiride · Drug: metformin hydrochloride · Drug: pioglitazone hydrochloride · Drug: Rosiglitazone

Interventions

  • Drugdapagliflozin

    tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks

  • DrugGlimepiride

    tablet oral 2.5, 5, or 10 mg total daily dose once daily 48 weeks

    Also known as: Amaryl

  • Drugmetformin hydrochloride

    rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

    Also known as: Glucophage

  • Drugpioglitazone hydrochloride

    rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

    Also known as: Actos

  • DrugRosiglitazone

    rescue medication oral dosing in accordance with the manufacturer's recommendations and clinical practice

    Also known as: Avandia

06

What researchers measure

Primary outcomes

  1. Adjusted Mean Change in HbA1c Levels

    To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.

    Time frame: Baseline to Week 24

Secondary outcomes

  1. Adjusted Mean Change in Body Weight

    To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.

    Time frame: Baseline to Week 24

  2. Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise

    To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.

    Time frame: Baseline to Week 24

  3. Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%

    To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c \< 7% after 24 weeks of treatment, compared to placebo plus glimepiride.

    Time frame: At Week 24

  4. Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2

    To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride.

    Time frame: Baseline to Week 24

  5. Adjusted Mean Change in Fasting Plasma Glucose (FPG)

    To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.

    Time frame: Baseline to Week 24

07

Results

Posted Oct 14, 2013
Limitations and caveats
For participants who did not complete 24 weeks LOCF (last observation carried forward) was used. Only values prior to rescue medication were used.

Participant flow

Enrollment: 859 (597 randomized and 592 in the Full Analysis Set) Study Start Date:April 2008 Study Completion Date:May 2010 Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)

Participant flow — Overall Study
MilestoneDapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + Glimepiride
Started154145151146
Completed140132141133
Not completed14131013
Withdrew: Withdrawal by subject8328
Withdrew: Lost to follow-up0110
Withdrew: Death1010
Withdrew: Adverse event5333
Withdrew: Poor/non-compliance0300
Withdrew: Subject no longer meets study criteria0202
Withdrew: False treatment0130

Outcome measures

PrimaryAdjusted Mean Change in HbA1c Levels

To assess the efficacy of dapagliflozin compared to placebo as add-on therapy to glimepiride in improving glycemic control in participants with type 2 diabetes, as determined by the change in HbA1C levels from baseline to the end of the 24-week double-blind treatment period.

Time frame:
Baseline to Week 24
Reported as:
Least squares mean · Percent
Adjusted Mean Change in HbA1c Levels
PercentDapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + Glimepiride
Adjusted Mean Change in HbA1c Levels-0.58 (-0.69 to -0.46)-0.63 (-0.75 to -0.50)-0.82 (-0.94 to -0.70)-0.13 (-0.26 to -0.01)
Statistical analysis
  • Dapagliflozin 2.5mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · p = <0.0001 (significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.) · Mean difference (final values): -0.44 · 95% CI -0.61 to -0.27with treatment group as effect (all treatment groups included) and baseline value as covariate.
  • Dapagliflozin 5mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · p = <0.0001 (significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.) · Mean difference (final values): -0.49 · 95% CI -0.67 to -0.32with treatment group as effect (all treatment groups included) and baseline value as covariate.
  • Dapagliflozin 10mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · p = <0.0001 (significant at alpha=0.019 (2-sided) applying Dunnett's adjustment. A hierarchical closed testing procedure was used to control the Type I error rate across the primary and key secondary endpoints.) · Mean difference (final values): -0.68 · 95% CI -0.86 to -0.51with treatment group as effect (all treatment groups included) and baseline value as covariate.
SecondaryAdjusted Mean Change in Body Weight

To show that dapagliflozin plus glimepiride results in greater reduction in body weight or less weight gain after 24 weeks of treatment when compared to placebo plus glimepiride.

Time frame:
Baseline to Week 24
Reported as:
Least squares mean · kg
Adjusted Mean Change in Body Weight
kgDapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + Glimepiride
Adjusted Mean Change in Body Weight-1.18 (-1.62 to -0.75)-1.56 (-2.01 to -1.11)-2.26 (-2.70 to -1.83)-0.72 (-1.16 to -0.28)
Statistical analysis
  • Dapagliflozin 2.5mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · p = 0.1410 (not significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.) · Mean difference (final values): -0.46 · 95% CI -1.08 to 0.15with treatment group as effect (all treatment groups included) and baseline value as covariate.
  • Dapagliflozin 5mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · p = 0.0091 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.) · Mean difference (final values): -0.84 · 95% CI -1.47 to -0.21with treatment group as effect (all treatment groups included) and baseline value as covariate.
  • Dapagliflozin 10mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · p = <0.0001 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.) · Mean difference (final values): -1.54 · 95% CI -2.17 to -0.92with treatment group as effect (all treatment groups included) and baseline value as covariate.
SecondaryAdjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise

To show that dapagliflozin plus glimepiride results in greater reductions in the 2-h post-challenge plasma glucose rise as a response to an oral glucose tolerance test (OGTT) from baseline to Week 24.

Time frame:
Baseline to Week 24
Reported as:
Least squares mean · mg/dL
Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise
mg/dLDapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + Glimepiride
Adjusted Mean Change in 2-h Post-challenge Plasma Glucose Rise-37.5 (-46.7 to -28.3)-32.0 (-41.5 to -22.5)-34.9 (-43.8 to -25.9)-6.0 (-15.8 to 3.9)
Statistical analysis
  • Dapagliflozin 2.5mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · Mean difference (final values): -31.5 · 95% CI -45.0 to -18.0with treatment group as effect (all treatment groups included) and baseline value as covariate.
  • Dapagliflozin 5mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · p = 0.0002 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.) · Mean difference (final values): -26.0 · 95% CI -39.7 to -12.3with treatment group as effect (all treatment groups included) and baseline value as covariate.
  • Dapagliflozin 10mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · p = <0.0001 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.) · Mean difference (final values): -28.9 · 95% CI -42.2 to -15.6with treatment group as effect (all treatment groups included) and baseline value as covariate.
SecondaryProportion of Participants Achieving Glycemic Response Defined as HbA1c <7%

To show that dapagliflozin plus glimepiride results in a larger proportion of participants achieving a therapeutic glycemic response, defined as HbA1c \< 7% after 24 weeks of treatment, compared to placebo plus glimepiride.

Time frame:
At Week 24
Reported as:
Least squares mean · Percentage of participants
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%
Percentage of participantsDapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + Glimepiride
Proportion of Participants Achieving Glycemic Response Defined as HbA1c <7%26.8 (20.2 to 33.3)30.3 (23.4 to 37.1)31.7 (24.7 to 38.7)13.0 (7.6 to 18.4)
Statistical analysis
  • Dapagliflozin 2.5mg + Glimepiride vs Placebo + Glimepiride · Regression, Logistic · Risk difference (rd): 13.7 · 95% CI 5.4 to 22.1Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.
  • Dapagliflozin 5mg + Glimepiride vs Placebo + Glimepiride · Regression, Logistic · p = 0.0001 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.) · Risk difference (rd): 17.3 · 95% CI 8.7 to 25.9Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.
  • Dapagliflozin 10mg + Glimepiride vs Placebo + Glimepiride · Regression, Logistic · p = <0.0001 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.) · Risk difference (rd): 18.7 · 95% CI 9.9 to 27.4Based on methodology of Zhang, Tsiatis \& Davidian and Davidian, Tsiatis, Zhang \& Lu, with adjustment for baseline value.
SecondaryAdjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2

To show that dapagliflozin plus glimepiride results in greater reductions in body weight or less weight gain in participants with baseline BMI ≥27 kg/m2 after 24 weeks of treatment when compared to placebo plus glimepiride.

Time frame:
Baseline to Week 24
Reported as:
Least squares mean · kg
Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2
kgDapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + Glimepiride
Adjusted Mean Change in Body Weight for Participants With Baseline Body Mass Index (BMI)≥27 kg/m2-1.17 (-1.75 to -0.59)-1.74 (-2.34 to -1.15)-2.47 (-3.06 to -1.88)-0.80 (-1.38 to -0.22)
Statistical analysis
  • Dapagliflozin 2.5mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · Mean difference (final values): -0.37 · 95% CI -1.19 to 0.45with treatment group as effect (all treatment groups included) and baseline value as covariate.
  • Dapagliflozin 5mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · p = 0.0262 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.) · Mean difference (final values): -0.94 · 95% CI -1.78 to -0.11with treatment group as effect (all treatment groups included) and baseline value as covariate.
  • Dapagliflozin 10mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · p = <0.0001 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.) · Mean difference (final values): -1.67 · 98% CI -2.50 to -0.84with treatment group as effect (all treatment groups included) and baseline value as covariate.
SecondaryAdjusted Mean Change in Fasting Plasma Glucose (FPG)

To show that dapagliflozin plus glimepiride leads to greater reductions in FPG after 24 weeks of treatment compared to placebo plus glimepiride.

Time frame:
Baseline to Week 24
Reported as:
Least squares mean · mg/dL
Adjusted Mean Change in Fasting Plasma Glucose (FPG)
mg/dLDapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + Glimepiride
Adjusted Mean Change in Fasting Plasma Glucose (FPG)-16.8 (-21.7 to -12.0)-21.2 (-26.3 to -16.2)-28.5 (-33.4 to -23.6)-2.0 (-6.9 to 3.0)
Statistical analysis
  • Dapagliflozin 2.5mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · Mean difference (final values): -14.9 · 95% CI -21.8 to -7.9with treatment group as effect (all treatment groups included) and baseline value as covariate.
  • Dapagliflozin 5mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · p = <0.0001 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.) · Mean difference (final values): -19.3 · 95% CI -26.3 to -12.2with treatment group as effect (all treatment groups included) and baseline value as covariate.
  • Dapagliflozin 10mg + Glimepiride vs Placebo + Glimepiride · ANCOVA · p = <0.0001 (significant at alpha=0.05 (2-sided). Primary and key secondary endpoints are tested following a hierarchical closed testing procedure within treatment group.) · Mean difference (final values): -26.5 · 95% CI -33.5 to -19.5with treatment group as effect (all treatment groups included) and baseline value as covariate.

Adverse events

Collected over Non-serious/serious adverse events on or after the first day and on or prior to the last day of the 24-week double-blind treatment period plus 4/30 days or up to follow-up visit if earlier, or up to and incl the start date of extension period if earlier.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dapagliflozin 2.5mg + Glimepiride—11/154 (7.1%)22/154 (14.3%)
Dapagliflozin 5mg + Glimepiride—10/145 (6.9%)19/145 (13.1%)
Dapagliflozin 10mg + Glimepiride—9/151 (6%)18/151 (11.9%)
Placebo + Glimepiride—7/146 (4.8%)15/146 (10.3%)
Most frequent serious events
Showing 10 of 40
Most frequent serious events
EventDapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + Glimepiride
DIABETES MELLITUSMetabolism and nutrition disorders0/1542/1450/1510/146
PNEUMONIAInfections and infestations1/1540/1452/1510/146
ANGINA PECTORISCardiac disorders1/1541/1450/1510/146
CORONARY ARTERY DISEASECardiac disorders0/1541/1450/1510/146
VERTIGOEar and labyrinth disorders0/1541/1450/1510/146
ARTHRITISMusculoskeletal and connective tissue disorders0/1541/1450/1510/146
BACK PAINMusculoskeletal and connective tissue disorders0/1541/1450/1510/146
NECK PAINMusculoskeletal and connective tissue disorders0/1541/1450/1510/146
ROTATOR CUFF SYNDROMEMusculoskeletal and connective tissue disorders0/1541/1450/1510/146
BENIGN BREAST NEOPLASMNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1541/1450/1510/146
Most frequent other events
Most frequent other events
EventDapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + Glimepiride
HypoglycemiaEndocrine disorders11/15410/14512/1517/146
NASOPHARYNGITISInfections and infestations3/1548/1455/1514/146
HYPERTENSIONVascular disorders8/1542/1452/1516/146

Baseline characteristics

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.

Age Continuous
Age Continuous(years)Dapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + GlimepirideTotal
Mean59.9 ± 10.1460.2 ± 9.7358.9 ± 8.3260.3 ± 10.1659.8 ± 9.60
Sex: Female, Male
Sex: Female, Male(Participants)Dapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + GlimepirideTotal
Female77718574307
Male77716671285
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Dapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + GlimepirideTotal
White10896106101411
Asian46464544181
BMI
BMI(kg/m2)Dapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + GlimepirideTotal
Mean30.01 ± 5.12029.84 ± 5.18229.75 ± 5.64129.74 ± 4.56929.84 ± 5.135
HbA1c
HbA1c(Percent)Dapagliflozin 2.5mg + GlimepirideDapagliflozin 5mg + GlimepirideDapagliflozin 10mg + GlimepiridePlacebo + GlimepirideTotal
Mean8.11 ± 0.7498.12 ± 0.7818.07 ± 0.7908.15 ± 0.7368.11 ± 0.763
08

Study locations

66 sites
  • Research Site
    Blansko, Czech Republic
  • Research Site
    Breclav, Czech Republic
  • Research Site
    Bruntal, Czech Republic
  • Research Site
    Hodonin, Czech Republic
  • Research Site
    Ostrava - Belsky Les, Czech Republic
  • Research Site
    Plzen, Czech Republic
  • Research Site
    Praha 1, Czech Republic
  • Research Site
    Pribram Viii, Czech Republic
  • Research Site
    Rakovnik, Czech Republic
  • Research Site
    Semily, Czech Republic
  • Research Site
    Balatonfured, Hungary
  • Research Site
    Bekescsaba, Hungary
  • Research Site
    Budapest, Hungary
  • Research Site
    Csongrad, Hungary
  • Research Site
    Eger, Hungary
  • Research Site
    Gyongyos, Hungary
  • Research Site
    Kecskemet, Hungary
  • Research Site
    Mako, Hungary
  • Research Site
    Miskolc, Hungary
  • Research Site
    Mosonmagyarovar, Hungary
  • Research Site
    Siofok, Hungary
  • Research Site
    Szentes, Hungary
  • Research Site
    TAT, Hungary
  • Research Site
    Zalaegerszeg, Hungary
  • Research Site
    Jeonju, Chonbuk, Korea, Republic of
  • Research Site
    Wonju, Kangwon-do, Korea, Republic of
  • Research Site
    Suwon, Kyunggi-do, Korea, Republic of
  • Research Site
    Bucheon, Korea, Republic of
  • Research Site
    Incheon, Korea, Republic of
  • Research Site
    Seongnam, Korea, Republic of
  • Research Site
    Seoul, Korea, Republic of
  • Research Site
    Uljeongbu, Korea, Republic of
  • Research Site
    Cebu City, Philippines
  • Research Site
    Manila, Philippines
  • Research Site
    Marikina City, Philippines
  • Research Site
    Pasig City, Philippines
  • Research Site
    Bielsko - Biala, Poland
  • Research Site
    Bydgoszcz, Poland
  • Research Site
    Chojnice, Poland
  • Research Site
    Chrzanow, Poland
  • Research Site
    Ciechocinek, Poland
  • Research Site
    Czechowice-Dziedzice, Poland
  • Research Site
    Elblag, Poland
  • Research Site
    Gdansk, Poland
  • Research Site
    Gniewkowo, Poland
  • Research Site
    Grudziadz, Poland
  • Research Site
    Ilawa, Poland
  • Research Site
    Krakow, Poland
  • Research Site
    Mragowo, Poland
  • Research Site
    Plock, Poland
  • Research Site
    Poznan, Poland
  • Research Site
    Ruda Slaska, Poland
  • Research Site
    Sopot, Poland
  • Research Site
    Torun, Poland
  • Research Site
    Wroclaw, Poland
  • Research Site
    Zabrze, Poland
  • Research Site
    Zielona Gora, Poland
  • Research Site
    Zory, Poland
  • Research Site
    Bangkok, Thailand
  • Research Site
    Chiang Mai, Thailand
  • Research Site
    Dnipropetrov'sk, Ukraine
  • Research Site
    Donetsk, Ukraine
  • Research Site
    Kharkiv, Ukraine
  • Research Site
    Kiev, Ukraine
  • Research Site
    Vinnytsia, Ukraine
  • Research Site
    Zaporozhye, Ukraine
09

References and documents

Publications

  • Shah M, Stolbov L, Yakovleva T, Tang W, Sokolov V, Penland RC, Boulton D, Parkinson J. A model-based approach to investigating the relationship between glucose-insulin dynamics and dapagliflozin treatment effect in patients with type 2 diabetes. Diabetes Obes Metab. 2021 Apr;23(4):991-1000. doi: 10.1111/dom.14305. Epub 2021 Jan 25. PubMed 33368935 ↗
  • Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. [Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride]. Dtsch Med Wochenschr. 2013 Apr;138 Suppl 1:S16-26. doi: 10.1055/s-0032-1305277. Epub 2013 Mar 25. German. PubMed 23529567 ↗
  • Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011 Oct;13(10):928-38. doi: 10.1111/j.1463-1326.2011.01434.x. PubMed 21672123 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00680745
Lead sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
May 20, 2008
Start date
Apr 2008
Primary completion
Nov 2009
Completion
May 2010
Results posted
Oct 14, 2013
Last update
Oct 14, 2013

Study contacts

Krzysztof Strojek, Prof. Dr.
principal investigator · Silesian Medical University3-Maja 13/15, 41-800 Zabrze; Poland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 2→

Other studies from this sponsor

AstraZeneca

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