NCT01498185

Brief Summary

To obtain safety and tolerability information in patients with type 1 diabetes where Dapagliflozin is added on to Insulin (for 14 days)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

February 10, 2017

Completed
Last Updated

February 10, 2017

Status Verified

December 1, 2016

Enrollment Period

8 months

First QC Date

December 21, 2011

Results QC Date

October 7, 2016

Last Update Submit

December 20, 2016

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7

    7-PGM was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the assessment on Day -1, prior to the start date and time of the first dose of the double-blind study medication. 7-PGM included the average of all available glucose values before and 2-hour (hr) after each meal (breakfast, lunch, dinner) as well as bedtime. Measurements were on Day -1, and Day 7 in the double-blind period.

    From Baseline to Day 7

Secondary Outcomes (7)

  • Dapagliflozin Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)

    Day 7 (0 hr to 24 hr post dose)

  • Dapagliflozin Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)

    Day 7 (0 hr to 24 hr post dose)

  • Dapagliflozin Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])

    Day 7 (0 hr to 24 hr post dose)

  • Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)

    Day 7 (0 hr to 24 hr post dose)

  • Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)

    Day 7 (0 hr to 24 hr post dose)

  • +2 more secondary outcomes

Study Arms (5)

Arm 1: Dapagliflozin (1 mg)

EXPERIMENTAL
Drug: Dapagliflozin

Arm 2: Dapagliflozin (2.5 mg)

EXPERIMENTAL
Drug: Dapagliflozin

Arm 3: Dapagliflozin (5 mg)

EXPERIMENTAL
Drug: Dapagliflozin

Arm 4: Dapagliflozin (10 mg)

EXPERIMENTAL
Drug: Dapagliflozin

Arm 5: Placebo matching Dapagliflozin

EXPERIMENTAL
Drug: Placebo matching Dapagliflozin

Interventions

DapagliflozinDRUG

Tablets, Oral, 1 mg, Once daily, 14 days

Arm 1: Dapagliflozin (1 mg)Arm 2: Dapagliflozin (2.5 mg)Arm 3: Dapagliflozin (5 mg)Arm 4: Dapagliflozin (10 mg)
Placebo matching DapagliflozinDRUG

Tablets, Oral, 0 mg, Once daily, 14 days

Arm 5: Placebo matching Dapagliflozin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes with central lab Glycosylated hemoglobin (A1C) ≥ 7.0% and ≤ 10.0%
  • Insulin use for at least 12 months and initiation immediately after diagnosis of diabetes
  • Method of Insulin administration \[multiple daily injections (MDI) or continuous subcutaneous Insulin infusion (CSII)\] stable ≥ 3 months
  • Stable basal Insulin dose ≥ 2 weeks
  • Ages 18 to 65 years
  • Central laboratory C-peptide value of \< 0.7 ng/mL
  • Body mass index (BMI) 18.5 to 35.0 kg/m2

You may not qualify if:

  • History of type 2 diabetes mellitus (T2DM), maturity onset diabetes of young (MODY), pancreatic surgery or chronic pancreatitis
  • Oral hypoglycemic agents
  • History of diabetes ketoacidosis (DKA) within 24 weeks
  • History of hospital admission for glycemic control within 6 months
  • Frequent episodes of hypoglycemia (2 unexplained within 3 months) or hypoglycemic unawareness
  • Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) or Serum total bilirubin \> 2X Upper limit of normal (ULN)
  • Abnormal Free T4 \[if screening Thyroid Stimulating Hormone (TSH) abnormal\]
  • Estimated glomerular filtration rate (eGFR) Modification of Diet in Renal Disease (MDRD) formula ≤ 60 mL/min/1.73m2
  • Cardiovascular (CV)/Vascular Diseases within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Profil Institute For Clinical Research, Inc.

Chula Vista, California, 91911, United States

Location

Va San Diego Healthcare System

San Diego, California, 92161, United States

Location

La Biomed Research Inst. At Harbor Ucla Med Ctr.

Torrance, California, 90502, United States

Location

Compass Research Phase 1, Llc

Orlando, Florida, 32806, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Vince And Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

Louisiana Research Associates, Inc.

New Orleans, Louisiana, 70114, United States

Location

Jasper Clinic, Inc.

Kalamazoo, Michigan, 49007, United States

Location

Kansas City University Of Medicine And Biosciences

Kansas City, Missouri, 64106, United States

Location

Regional Medical Clinic-Endocrinology

Rapid City, South Dakota, 57701, United States

Location

Dallas Diabetes & Endocrine Center

Dallas, Texas, 75230, United States

Location

Related Publications (2)

  • Melin J, Tang W, Rekic D, Hamren B, Penland RC, Boulton DW, Parkinson J. Dapagliflozin Pharmacokinetics Is Similar in Adults With Type 1 and Type 2 Diabetes Mellitus. J Clin Pharmacol. 2022 Oct;62(10):1227-1235. doi: 10.1002/jcph.2062. Epub 2022 May 2.

    PMID: 35403243DERIVED

  • Henry RR, Rosenstock J, Edelman S, Mudaliar S, Chalamandaris AG, Kasichayanula S, Bogle A, Iqbal N, List J, Griffen SC. Exploring the potential of the SGLT2 inhibitor dapagliflozin in type 1 diabetes: a randomized, double-blind, placebo-controlled pilot study. Diabetes Care. 2015 Mar;38(3):412-9. doi: 10.2337/dc13-2955. Epub 2014 Sep 30.

    PMID: 25271207DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Anna Maria Langkilde
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2011

First Posted

December 23, 2011

Study Start

February 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 10, 2017

Results First Posted

February 10, 2017

Record last verified: 2016-12

Locations

US(12)