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Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2) (INSTRIDE 2)

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ClinicalTrials.gov Identifier: NCT02227875
Recruitment Status : Completed
First Posted : August 28, 2014
Results First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Collaborator:
Mylan GmbH
Information provided by (Responsible Party):
Mylan Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: Mylan's insulin glargine
Drug: Lantus®
Enrollment 560
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mylan's Insulin Glargine Lantus®
Hide Arm/Group Description

receive Mylan's insulin Glargine

Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

receive Lantus®

Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Period Title: Overall Study
Started 277 283
Completed 240 250
Not Completed 37 33
Reason Not Completed
Protocol Violation             10             7
Other             1             3
Physician Decision             1             0
Adverse Event             3             0
Withdrawal by Subject             12             13
Lost to Follow-up             10             10
Arm/Group Title Mylan's Insulin Glargine Lantus® Total
Hide Arm/Group Description

receive Mylan's insulin Glargine

Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

receive Lantus®

Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Total of all reporting groups
Overall Number of Baseline Participants 277 283 560
Hide Baseline Analysis Population Description
Recruitment details: Gender: male or female; Age: 18-65 years, inclusive; Body mass index (BMI): 18.5-40.0 kg/m2, inclusive
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 277 participants 283 participants 560 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
267
  96.4%
267
  94.3%
534
  95.4%
>=65 years
10
   3.6%
16
   5.7%
26
   4.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 277 participants 283 participants 560 participants
55  (7.91) 55.1  (7.5) 55.1  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 277 participants 283 participants 560 participants
Female
130
  46.9%
118
  41.7%
248
  44.3%
Male
147
  53.1%
165
  58.3%
312
  55.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 277 participants 283 participants 560 participants
South Korea 3 4 7
United States 225 228 453
Taiwan 1 0 1
South Africa 12 15 27
Slovakia 34 33 67
Jordan 2 3 5
1.Primary Outcome
Title Change in HbA1c From Baseline to 24 Weeks
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Mylan's Insulin Glargine Lantus®
Hide Arm/Group Description:

receive Mylan's insulin Glargine

Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

receive Lantus®

Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Overall Number of Participants Analyzed 274 278
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent
-0.6
(-0.779 to -0.414)
-0.66
(-0.837 to -0.475)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mylan's Insulin Glargine, Lantus®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Mixed-Effect Model for Repeated Measures
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.098 to 0.218
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Rate of Hypoglycemic Events Per 30 Days
Hide Description The change from baseline at 12 and 24 weeks is reported
Time Frame Baseline and up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Mylan's Insulin Glargine Lantus®
Hide Arm/Group Description:

receive Mylan's insulin Glargine

Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

receive Lantus®

Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Overall Number of Participants Analyzed 276 282
Mean (Standard Deviation)
Unit of Measure: Episodes/30 Days
week 12 0.341  (1.8963) 0.24  (2.0551)
week 24 -0.057  (0.919) -0.102  (1.6791)
3.Secondary Outcome
Title Hypoglycemia Occurrence
Hide Description Overall hypoglycemic incidence during treatment period
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Mylan's Insulin Glargine Lantus®
Hide Arm/Group Description:

receive Mylan's insulin Glargine

Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

receive Lantus®

Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Overall Number of Participants Analyzed 276 282
Measure Type: Number
Unit of Measure: number of events
Any hypoglycemic event 130 136
Severe Hypoglycemia 0 1
Documented Symptomatic Hypoglycemia 75 76
Asymptomatic Hypoglycemia 85 92
Probable Symptomatic Hypoglycemia 7 4
Relative Hypoglycemia 20 11
Unknown 29 25
4.Secondary Outcome
Title Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
Hide Description Comparison of change from Baseline in Immunogenicity
Time Frame Week 12 and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Mylan's Insulin Glargine Lantus®
Hide Arm/Group Description:

receive Mylan's insulin Glargine

Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

receive Lantus®

Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Overall Number of Participants Analyzed 276 282
Mean (Standard Deviation)
Unit of Measure: percentage of specific binding (SB)
week 12 1.9238  (12.54369) 0.6585  (8.05473)
week 24 1.7802  (9.64745) 0.7838  (8.15086)
5.Secondary Outcome
Title Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time
Hide Description Comparison of change from Baseline in Immunogenicity
Time Frame week 12 and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Mylan's Insulin Glargine Lantus®
Hide Arm/Group Description:

receive Mylan's insulin Glargine

Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

receive Lantus®

Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Overall Number of Participants Analyzed 276 282
Mean (Standard Deviation)
Unit of Measure: percentage of SB
week 12 1.787  (11.67578) 0.6462  (7.56375)
week 24 1.6866  (9.57132) 0.8212  (8.1084)
6.Secondary Outcome
Title Change in Cross-Reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time
Hide Description Comparison of change from Baseline in Immunogenicity
Time Frame week 12 and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Mylan's Insulin Glargine Lantus®
Hide Arm/Group Description:

receive Mylan's insulin Glargine

Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

receive Lantus®

Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Overall Number of Participants Analyzed 276 282
Mean (Standard Deviation)
Unit of Measure: percentage of SB
week 12 1.7488  (11.68129) 0.5116  (7.25175)
week 24 1.6301  (9.11098) 0.7524  (7.93317)
7.Secondary Outcome
Title Change in Cross-Reactive Insulin Antibody Percent Binding for Lantus Assay Over Time
Hide Description Comparison of change from Baseline in Immunogenicity
Time Frame Week 12 and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Mylan's Insulin Glargine Lantus®
Hide Arm/Group Description:

receive Mylan's insulin Glargine

Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

receive Lantus®

Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

Overall Number of Participants Analyzed 276 282
Mean (Standard Deviation)
Unit of Measure: percentage of SB
week 12 1.5994  (10.64782) 0.5014  (6.72058)
week 24 1.5648  (9.04243) 0.8361  (7.96308)
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mylan's Insulin Glargine Lantus®
Hide Arm/Group Description

receive Mylan's insulin Glargine

Mylan's insulin glargine: Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.

receive Lantus®

Lantus®: For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.

All-Cause Mortality
Mylan's Insulin Glargine Lantus®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/276 (0.00%)      0/282 (0.00%)    
Hide Serious Adverse Events
Mylan's Insulin Glargine Lantus®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/276 (2.90%)      9/282 (3.19%)    
Eye disorders     
Eye haemorrhage  1  1/276 (0.36%)  1 0/282 (0.00%)  0
Gastrointestinal disorders     
Gastric ulcer  1  1/276 (0.36%)  1 0/282 (0.00%)  0
Pancreatitis  1  1/276 (0.36%)  1 0/282 (0.00%)  0
Pancreatitis acute  1  1/276 (0.36%)  1 0/282 (0.00%)  0
General disorders     
Non-cardiac chest pain  1  1/276 (0.36%)  1 0/282 (0.00%)  0
Infections and infestations     
Bronchitis  1  1/276 (0.36%)  1 1/282 (0.35%)  1
Meningitis viral  1  0/276 (0.00%)  0 1/282 (0.35%)  1
Paraspinal abscess  1  1/276 (0.36%)  1 0/282 (0.00%)  0
Investigations     
Helicobacter test positive  1  1/276 (0.36%)  1 0/282 (0.00%)  0
Hepatic enzyme increased  1  1/276 (0.36%)  1 0/282 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  0/276 (0.00%)  0 1/282 (0.35%)  1
Hyperosmolar hyperglycaemic state  1  0/276 (0.00%)  0 1/282 (0.35%)  1
Hypoglycaemia  1  0/276 (0.00%)  0 1/282 (0.35%)  2
Lactic acidosis  1  0/276 (0.00%)  0 1/282 (0.35%)  1
Musculoskeletal and connective tissue disorders     
Cervical spinal stenosis  1  1/276 (0.36%)  1 0/282 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Endometrial adenocarcinoma  1  0/276 (0.00%)  0 1/282 (0.35%)  1
Squamous cell carcinoma of skin  1  0/276 (0.00%)  0 1/282 (0.35%)  2
Nervous system disorders     
Cerebrovascular accident  1  0/276 (0.00%)  0 1/282 (0.35%)  1
Renal and urinary disorders     
Acute kidney injury  1  0/276 (0.00%)  0 2/282 (0.71%)  2
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/276 (0.36%)  1 0/282 (0.00%)  0
Chronic obstructive pulmonary  1  0/276 (0.00%)  0 1/282 (0.35%)  1
Hypoxia  1  1/276 (0.36%)  1 0/282 (0.00%)  0
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Mylan's Insulin Glargine Lantus®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   177/276 (64.13%)      164/282 (58.16%)    
Gastrointestinal disorders     
Nausea  1  6/276 (2.17%)  6 4/282 (1.42%)  4
Vomiting  1  5/276 (1.81%)  5 5/282 (1.77%)  5
Diarrhoea  1  4/276 (1.45%)  4 5/282 (1.77%)  10
Abdominal pain  1  4/276 (1.45%)  4 1/282 (0.35%)  1
Constipation  1  3/276 (1.09%)  5 0/282 (0.00%)  0
Dyspepsia  1  3/276 (1.09%)  3 0/282 (0.00%)  0
Gastrooesophageal reflux disease  1  1/276 (0.36%)  1 3/282 (1.06%)  3
General disorders     
Fatigue  1  4/276 (1.45%)  4 2/282 (0.71%)  2
Injection site pain  1  3/276 (1.09%)  4 2/282 (0.71%)  3
Oedema peripheral  1  2/276 (0.72%)  2 6/282 (2.13%)  6
Immune system disorders     
Seasonal allergy  1  1/276 (0.36%)  1 4/282 (1.42%)  4
Infections and infestations     
Upper respiratory tract infection  1  17/276 (6.16%)  19 15/282 (5.32%)  15
Urinary tract infection  1  12/276 (4.35%)  13 8/282 (2.84%)  8
Nasopharyngitis  1  10/276 (3.62%)  11 13/282 (4.61%)  14
Sinusitis  1  8/276 (2.90%)  9 4/282 (1.42%)  5
Influenza  1  6/276 (2.17%)  7 3/282 (1.06%)  3
Bronchitis  1  5/276 (1.81%)  5 7/282 (2.48%)  7
Gastroenteritis  1  5/276 (1.81%)  5 1/282 (0.35%)  1
Pharyngitis  1  3/276 (1.09%)  3 1/282 (0.35%)  1
Pneumonia  1  3/276 (1.09%)  3 0/282 (0.00%)  0
Vulvovaginal mycotic infection  1  3/276 (1.09%)  3 0/282 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion  1  1/276 (0.36%)  1 4/282 (1.42%)  4
Laceration  1  0/276 (0.00%)  0 4/282 (1.42%)  4
Investigations     
Lipase increased  1  4/276 (1.45%)  4 1/282 (0.35%)  1
Metabolism and nutrition disorders     
Hypoglycemia  1  75/276 (27.17%)  330 66/282 (23.40%)  282
Musculoskeletal and connective tissue disorders     
Back pain  1  7/276 (2.54%)  7 6/282 (2.13%)  6
Pain in extremity  1  5/276 (1.81%)  5 4/282 (1.42%)  4
Arthralgia  1  4/276 (1.45%)  4 5/282 (1.77%)  7
Musculoskeletal pain  1  2/276 (0.72%)  2 5/282 (1.77%)  5
Nervous system disorders     
Headache  1  8/276 (2.90%)  9 10/282 (3.55%)  11
Tremor  1  6/276 (2.17%)  9 1/282 (0.35%)  3
Dizziness  1  4/276 (1.45%)  4 7/282 (2.48%)  8
Renal and urinary disorders     
Nephrolithiasis  1  3/276 (1.09%)  3 0/282 (0.00%)  0
Dysuria  1  0/276 (0.00%)  0 3/282 (1.06%)  3
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  5/276 (1.81%)  5 5/282 (1.77%)  5
Cough  1  4/276 (1.45%)  4 10/282 (3.55%)  10
Respiratory tract congestion  1  3/276 (1.09%)  3 0/282 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash  1  2/276 (0.72%)  3 3/282 (1.06%)  3
Pruritus  1  1/276 (0.36%)  1 3/282 (1.06%)  3
Vascular disorders     
Hypertension  1  6/276 (2.17%)  6 2/282 (0.71%)  2
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Keri L. Vaughan, Director Global Clinical Operations, General Medicine
Organization: Mylan, Inc.
EMail: keri.vaughan@mylan.com
Layout table for additonal information
Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT02227875    
Other Study ID Numbers: MYL-GAI-3002
First Submitted: August 26, 2014
First Posted: August 28, 2014
Results First Submitted: February 24, 2020
Results First Posted: August 13, 2020
Last Update Posted: August 13, 2020