NCT02104804

Brief Summary

A Multicenter, Randomized, Double-Blind, Phase 3b Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination with Metformin in Chinese Subjects in China with Type 2 Diabetes Who Have Inadequate Glycaemic Control on Insulin Alone or on Insulin in Combination with Metformin

Trial Health

87
On Track

Trial Health Score

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

Enrollment
953

participants targeted

Target at P75+ for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started May 2014

Typical duration for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

11 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

April 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 7, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2016

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 2, 2017

Completed
Last Updated

October 2, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

April 2, 2014

Results QC Date

February 24, 2017

Last Update Submit

May 4, 2017

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Insulin, Dipeptidyl-Peptidase 4 Inhibitors, Metformin,saxagliptin,Endocrine System Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c From Baseline to Week 24

    Baseline to 24 weeks

Secondary Outcomes (5)

  • Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test

    Baseline to 24 weeks

  • Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test

    Baseline to 24 weeks

  • Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7%

    At Week 24

  • The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24)

    Baseline to Average of Weeks 20 and 24

  • Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24

    Baseline to 24 weeks

Study Arms (2)

Saxagliptin 5mg

EXPERIMENTAL

Saxagliptin 5mg, administered to subjects with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin

Drug: Saxagliptin 5mg

Placebo

PLACEBO COMPARATOR

Placebo administered to subjects with Type 2 diabetes inadequately controlled with insulin alone or with insulin plus metformin

Drug: Placebo for Saxagliptin

Interventions

Saxagliptin 5mgDRUG

Saxagliptin 5mg (plus stable insulin dose), given orally once daily (24 weeks); subjects stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue).

Also known as: Insulin: intermediate-acting or basal or premixed ( include short- or rapid-acting insulin as one component). ≥20 unit/day, ≤150 units/day, Metformin: Glucophage, 500-2500mg/day
Saxagliptin 5mg
Placebo for SaxagliptinDRUG

Placebo tablets (plus stable insulin dose), given orally once daily (24 weeks); subjects stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue).

Also known as: Insulin: intermediate-acting or basal or premixed ( include short- or rapid-acting insulin as one component). ≥20 unit/day, ≤150 units/day, Metformin: Glucophage, 500-2500mg/day
Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent before participating in the study.
  • Diagnosed with type 2 diabetes.
  • Inadequate glycemic control (screening: HbA1c ≥7.5% and ≤11.0% and FPG\<270 mg/dL (15mmol/L). At Day -4 visit, HbA1c ≥7.5% and ≤10.5%. and FPG\<270 mg/dL (15mmol/L)).
  • On a stable dose of insulin for 8 weeks or longer prior to screening.
  • If taking metformin, subjects should have been taking the same daily dose for 8 weeks or longer prior to screening.
  • Insulin type should be intermediate-acting or long-acting (basal) or premixed (premixed formulation may include short- or rapid-acting insulin as one component).
  • Body mass index ≤45 kg/m\^2.

You may not qualify if:

  • Women of childbearing potential unable or unwilling to use acceptable birth control.
  • Women who are pregnant or breastfeeding.
  • Symptoms of poorly controlled diabetes. including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the last three months prior to screening or other signs and symptoms.
  • Significant cardiovascular history defined as: myocardial infarction, coronary angioplasty or bypass graft, valvular disease or repair, unstable clinical significant arrhythmia, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident.
  • Congestive heart failure
  • Chronic or repeated intermittent corticosteroid treatment (subjects receiving stable doses of replacement corticosteroid (except dexamethasone) therapy may be enrolled).
  • History of unstable or rapidly progressing renal disease.
  • History of alcohol or drug abuse within the previous year.
  • Unstable major psychiatric disorders.
  • History of hemoglobinopathies
  • Immunocompromised status
  • Severe liver disease.
  • In subjects treated with insulin alone a calculated creatinine clearance \<50 ml/min. In patients treated with insulin in combination with metformin a calculated creatinine clearance \<60 ml/min or serum creatinine \> 1.5 mg/dL in males or \> 1.4mg/dL in females.
  • Anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Research Site

Beijing, China

Location

Research Site

Changchun, China

Location

Research Site

Fuzhou, China

Location

Research Site

Guangzhou, China

Location

Research Site

Ha'er Bing, China

Location

Research Site

Hefei, China

Location

Research Site

Nanchang, China

Location

Research Site

Nanjing, China

Location

Research Site

Shanghai, China

Location

Research Site

Shijiazhuang, China

Location

Research Site

Shiyan, China

Location

Related Publications (7)

  • Drucker DJ. Dipeptidyl peptidase-4 inhibition and the treatment of type 2 diabetes: preclinical biology and mechanisms of action. Diabetes Care. 2007 Jun;30(6):1335-43. doi: 10.2337/dc07-0228. Epub 2007 Mar 2. No abstract available.

    PMID: 17337495RESULT

  • Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.

    PMID: 1244564RESULT

  • Fonseca V, Schweizer A, Albrecht D, Baron MA, Chang I, Dejager S. Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes. Diabetologia. 2007 Jun;50(6):1148-55. doi: 10.1007/s00125-007-0633-0. Epub 2007 Mar 27.

    PMID: 17387446RESULT

  • Pan CY, Yang W, Tou C, Gause-Nilsson I, Zhao J. Efficacy and safety of saxagliptin in drug-naive Asian patients with type 2 diabetes mellitus: a randomized controlled trial. Diabetes Metab Res Rev. 2012 Mar;28(3):268-75. doi: 10.1002/dmrr.1306.

    PMID: 22081481RESULT

  • Vilsboll T, Rosenstock J, Yki-Jarvinen H, Cefalu WT, Chen Y, Luo E, Musser B, Andryuk PJ, Ling Y, Kaufman KD, Amatruda JM, Engel SS, Katz L. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Feb;12(2):167-77. doi: 10.1111/j.1463-1326.2009.01173.x.

    PMID: 20092585RESULT

  • Yang W, Pan CY, Tou C, Zhao J, Gause-Nilsson I. Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: a randomized controlled trial. Diabetes Res Clin Pract. 2011 Nov;94(2):217-24. doi: 10.1016/j.diabres.2011.07.035. Epub 2011 Aug 26.

    PMID: 21871686RESULT

  • Chen Y, Liu X, Li Q, Ma J, Lv X, Guo L, Wang C, Shi Y, Li Y, Johnsson E, Wang M, Zhao J, Ji L. Saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin with or without metformin: Results from the SUPER study, a randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2018 Apr;20(4):1044-1049. doi: 10.1111/dom.13161. Epub 2017 Dec 18.

    PMID: 29144061DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

saxagliptinInsulin, Short-Acting

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

InsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Eva Johnsson, MD, PhD, Global Clinical Lead
Organization
AstraZeneca
Eva.Johnsson@astrazeneca.com

Study Officials

  • Linong Ji, Professor

    People's Hospital of Peking Universty

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 4, 2014

Study Start

May 7, 2014

Primary Completion

February 26, 2016

Study Completion

February 26, 2016

Last Updated

October 2, 2017

Results First Posted

October 2, 2017

Record last verified: 2017-04

Locations

CN(11)