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Trial record 1 of 1 for:    LANTUL07190
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Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL)

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ClinicalTrials.gov Identifier: NCT02545842
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To identify a best fasting plasma glucose (FPG) target for Chinese type 2 diabetes patients using insulin glargine which can provide the highest control rate of glycated hemoglobin (HbA1c) < 7%.

Secondary Objectives:

The control rate of HbA1c ≤6.5% achievement. The control rate of HbA1c <7.0% in patients achieving their FPG target. The percentage of HbA1c <7% without hypoglycemia. The percentage of patients achieving the FPG target without hypoglycemia. The percentage of patients achieving the FPG target and post prandial glucose (PPG) target (2-hour post breakfast <10 mmol/L).


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: INSULIN GLARGINE Phase 4

Detailed Description:
The study duration for each patient will be 27 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 947 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Titration Target for Chinese Type 2 Diabetes Mellitus Patients Using Insulin Glargine to Achieve Glycaemic Goals: An Assessment of Three Different Fasting Plasma Glucose Targets - BEYOND III/FPG GOAL Study
Study Start Date : September 7, 2015
Actual Primary Completion Date : April 20, 2018
Actual Study Completion Date : April 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Insulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of <=5.6 mmol/L
Drug: INSULIN GLARGINE

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: HOE901

Experimental: Group 2
Insulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of <=6.1 mmol/L
Drug: INSULIN GLARGINE

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: HOE901

Experimental: Group 3
Insulin glargine will be administered once daily at bedtime (preferably between 9:00 PM and 11:00 PM) by subcutaneous injection in the abdomen (preferred route) with FPG target of <=7.0 mmol/L
Drug: INSULIN GLARGINE

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: HOE901




Primary Outcome Measures :
  1. Percentage of patients with HbA1c <7% achievement [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Percentage of patients achieving HbA1c <=6.5% [ Time Frame: 24 weeks ]
  2. Percentage of patients achieving FPG target with HbA1c <7% [ Time Frame: 24 weeks ]
  3. Percentage of patients achieving HbA1c <7% without hypoglycemia [ Time Frame: 24 weeks ]
  4. Percentage of patients achieving the FPG target without hypoglycemia [ Time Frame: 24 weeks ]
  5. Percentage of patients achieving FPG target [ Time Frame: 24 weeks ]
  6. Percentage of patients achieving PPG target (2-hour post-breakfast <10 mmol/L) [ Time Frame: 24 weeks ]
  7. Change from baseline in HbA1c [ Time Frame: Baseline to 24 weeks ]
  8. Change in FPG [ Time Frame: 8 weeks to 24 weeks ]
  9. Change in PPG [ Time Frame: Baseline to 24 weeks ]
  10. Change in insulin doses in each arm [ Time Frame: 1 week to 24 weeks ]
  11. Change in body weight in each treatment arm [ Time Frame: Baseline to 24 weeks ]
  12. Percentage of patients experienced hypoglycemic events [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • 18 to 65 years old.
  • Type 2 diabetes patients insufficient controlled by 1-3 oral anti-hyperglycemic drugs (OADs) with stable dose at least 3 months:
  • If on 1 OAD, provided with the following doses (including but not limited to):

    • α-glucosidase inhibitor: 100mg, three times a day (tid);
    • metformin: 1.5-2.0 g/day;
    • sulphonylureas: sub-maximum (half dose above) to maximum tolerated dose;
    • thiazolidinediones: eg. pioglitazone, 30-40 mg/day.
    • Besides the medications listed above, if on 1 OAD, others should be maximum tolerated dose allowed in package insert.
  • If on 2-3 OADs, any range of dose is acceptable.
  • HbA1c >7%, and ≤10.5%.
  • FPG >7 mmol/L.
  • Body mass index (BMI) ≥20 kg/m^2, and ≤40 kg/m^2.
  • Diabetes duration ≥1 year.
  • Physician decides to and the patient is willing to start basal insulin (BI) treatment.
  • Willing to join the study and sign the informed consent.

Exclusion criteria:

  • Type 1 diabetes patients.
  • Patients with acute diabetic complications (including unexplained severe hypoglycemia in the last 6 months).
  • Previous treatment with insulin for more than 1 month cumulatively in last 1 year, or treatment with insulin in the last 3 months before the screening.
  • Known hypoglycemia unawareness or recurrent hypoglycemia.
  • Hypersensitivity to study drug or its excipients.
  • Any clinically significant acute major organ or systemic disease, or any other situation judged by the Investigator, that is difficult for the 24 weeks follow-up.
  • Pregnancy or breastfeeding women.
  • Have any mental disorders, lack self-control or not able to express accurately.
  • Involved in another clinical trial simultaneously or within a 1 month before start of trial.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545842


Locations
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China
Investigational Site Number 156053
Anshan, China
Investigational Site Number 156001
Beijing, China
Investigational Site Number 156002
Beijing, China
Investigational Site Number 156006
Beijing, China
Investigational Site Number 156013
Changchun, China, 130033
Investigational Site Number 156014
Changchun, China, 130033
Investigational Site Number 156022
Changde, China, 415000
Investigational Site Number 156017
Changsha, China
Investigational Site Number 156034
Changzhou, China
Investigational Site Number 156023
Chenzhou, China
Investigational Site Number 156026
Guangzhou, China, 510515
Investigational Site Number 156029
Haikou, China, 570102
Investigational Site Number 156028
Haikou, China
Investigational Site Number 156040
Haikou, China
Investigational Site Number 156039
Hangzhou, China, 310013
Investigational Site Number 156038
Hangzhou, China
Investigational Site Number 156042
Hangzhou, China
Investigational Site Number 156044
Hangzhou, China
Investigational Site Number 156048
Hefei, China
Investigational Site Number 156050
Hefei, China
Investigational Site Number 156011
Kunming, China
Investigational Site Number 156052
Kunming, China
Investigational Site Number 156016
Lanzhou, China
Investigational Site Number 156041
Lishui, China
Investigational Site Number 156020
Nanchang, China, 330006
Investigational Site Number 156018
Nanchang, China
Investigational Site Number 156019
Nanchang, China
Investigational Site Number 156031
Nanjing, China
Investigational Site Number 156043
Nanjing, China
Investigational Site Number 156049
Nanjing, China
Investigational Site Number 156035
Shanghai, China
Investigational Site Number 156036
Shanghai, China
Investigational Site Number 156047
Shanghai, China
Investigational Site Number 156027
Shantou, China
Investigational Site Number 156015
Shenyang, China
Investigational Site Number 156054
Shijiazhuang, China
Investigational Site Number 156007
Tangshan, China, 063000
Investigational Site Number 156010
Tianjin, China, 300032
Investigational Site Number 156055
Wuhan, China, 430000
Investigational Site Number 156037
Xuzhou, China
Investigational Site Number 156033
Yangzhou, China
Investigational Site Number 156030
Yueyang, China
Investigational Site Number 156032
Zhenjiang, China, 212001
Investigational Site Number 156025
Zhuzhou, China, 412000
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02545842     History of Changes
Other Study ID Numbers: LANTUL07190
U1111-1172-1058 ( Other Identifier: UTN )
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs