Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy (EDITION III)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT01676220

First received: August 28, 2012

Last updated: May 28, 2015

Last verified: May 2015

History of Changes

Results First Received: March 24, 2015

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Type 2 Diabetes Mellitus
Interventions:	Drug: HOE901-U300 (new formulation of insulin glargine) Drug: Lantus (insulin glargine)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 1396 participants were screened, of whom 518 participants were screen failure and 878 participants were randomized.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
HOE901-U300	HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus (Insulin Glargine)	Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).

Participant Flow: Overall Study

	HOE901-U300	Lantus (Insulin Glargine)
STARTED	439	439
Treated	435	438
Modified Intent-To-Treat Population	432 ^[1]	430 ^[1]
COMPLETED	337	314
NOT COMPLETED	102	125
Randomized But Not Treated	4	1
Adverse Event	10	8
Lack of Efficacy	2	5
Protocol Violation	11	12
Received Rescue Therapy	14	22
Personal Reason	34	45
Lost to Follow-up	11	18
Selection Criterion/Protocol Violation	9	9
Site Closure/Site Withdrawal	1	4
Perceived Lack of Efficacy	3	1
Non Serious Hypoglycemia	2	0
No More Need of Insulin	1	0

^[1]	Participants who received at least 1 dose of drug, had both baseline, at least 1 postbaseline data

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized population: all screened participants (who originally met inclusion criteria and signed informed consent) allocated to a treatment group and recorded in Interactive Voice/Web Response System (IVRS/IWRS) database, regardless of whether treatment was used or not. Participants were analyzed in treatment group to which they were randomized.

Reporting Groups

	Description
HOE901-U300	HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Lantus	Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
Total	Total of all reporting groups

Baseline Measures

HOE901-U300

Lantus

Total

Overall Participants Analyzed
[Units: Participants]

439

878

Age
[Units: Years]
Mean (Standard Deviation)

58.2 (9.9)

57.2 (10.3)

57.7 (10.1)

Gender
[Units: Participants]

Female

186

185

371

Male

253

254

507

Body Mass Index (BMI)
[Units: Kilogram per square meter]
Mean (Standard Deviation)

32.8 (6.9)

33.2 (6.6)

33.0 (6.7)

Duration of Diabetes ^[1]
[Units: Years]
Mean (Standard Deviation)

10.11 (6.49)

9.57 (6.22)

9.84 (6.36)

^[1]	Number of participants analyzed for this baseline characteristics = 435 and 436 in HOE901-U300 and Lantus arm, respectively.

Basal Insulin Daily Dose ^[1]
[Units: Units per kilogram (U/kg)]
Mean (Standard Deviation)

0.193 (0.027)

0.193 (0.034)

0.193 (0.031)

^[1]	Number of participants analyzed for this baseline characteristics = 432 and 436 in HOE901-U300 and Lantus arm, respectively.

Glycated Hemoglobin A1c (HbA1c)
[Units: Participants]

Less Than (<) 8%

141

142

283

Greater Than or Equal to (>=) 8%

298

297

595

Outcome Measures

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1. Primary:

Change in HbA1c From Baseline to Month 6 Endpoint [ Time Frame: Baseline, Month 6 ]

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2. Secondary:

Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 [ Time Frame: Week 9 Up to Month 6 ]

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3. Secondary:

Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint [ Time Frame: Baseline, Month 6 ]

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4. Secondary:

Variability of Preinjection SMPG at Month 6 Endpoint [ Time Frame: Month 6 ]

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5. Secondary:

Percentage of Participants With HbA1c <7% at Month 6 [ Time Frame: Month 6 ]

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6. Secondary:

Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint [ Time Frame: Baseline, Month 6 ]

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7. Secondary:

Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6 [ Time Frame: Month 6 ]

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8. Secondary:

Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 [ Time Frame: Baseline, Month 6 ]

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9. Secondary:

Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint [ Time Frame: Baseline, Month 6 ]

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10. Secondary:

Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint [ Time Frame: Baseline, Month 6 ]

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11. Secondary:

Change in Daily Basal Insulin Dose From Baseline to Month 6 [ Time Frame: Baseline, Month 6 ]

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12. Secondary:

Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint [ Time Frame: Baseline, Month 6 ]

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13. Secondary:

Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12 [ Time Frame: Up to 12 months ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.

Results Point of Contact:

Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact -US@sanofi.com

Publications of Results:

Bolli GB, Riddle MC, Bergenstal RM, Ziemen M, Sestakauskas K, Goyeau H, Home PD; on behalf of the EDITION 3 study investigators. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes Metab. 2015 Apr;17(4):386-94. doi: 10.1111/dom.12438. Epub 2015 Feb 12.

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT01676220 History of Changes
Other Study ID Numbers:	EFC12347 2012-000146-35 ( EudraCT Number ) U1111-1124-5261 ( Other Identifier: UTN )
Study First Received:	August 28, 2012
Results First Received:	March 24, 2015
Last Updated:	May 28, 2015

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