Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus (PUMP)

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00607087

First received: January 23, 2008

Last updated: August 26, 2010

Last verified: August 2010

History of Changes

Results First Received: June 30, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 1
Interventions:	Drug: Insulin glulisine Drug: Insulin lispro Drug: Insulin aspart

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
Multicenter study: 44 active centers from 12 countries in Europe, USA and Asia Pacific region. Study Initiation date: January 8, 2008, Study Completion Date: June 15, 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
359 participants screened; 289 randomized; 288 patients treated (1 patient not treated per physician's decision): 274 with insulin glulisine, 269 with insulin lispro, 266 with insulin aspart. The safety population, (N=288 patients randomized and treated) is described in the participant flow and baseline characteristics.

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

359 participants screened; 289 randomized; 288 patients treated (1 patient not treated per physician's decision): 274 with insulin glulisine, 269 with insulin lispro, 266 with insulin aspart.

The safety population, (N=288 patients randomized and treated) is described in the participant flow and baseline characteristics.

Reporting Groups

	Description
Sequence 1	insulin glulisine / insulin aspart / insulin lispro
Sequence 2	insulin aspart / insulin lispro / insulin glulisine
Sequence 3	insulin lispro / insulin glulisine / insulin aspart

Participant Flow for 4 periods

Period 1: Overall Study

	Sequence 1	Sequence 2	Sequence 3
STARTED	99	95	94
COMPLETED	84	84	84
NOT COMPLETED	15	11	10
Withdrawal by Subject	9	4	4
Adverse Event	3	2	3
Other reason	1	5	2
Poor compliance to protocol	1	0	1
Lost to Follow-up	1	0	0

Period 2: Period 1

	Sequence 1	Sequence 2	Sequence 3
STARTED	99	95	94
COMPLETED	87	89	89
NOT COMPLETED	12	6	5
Withdrawal by Subject	7	2	3
Adverse Event	3	0	0
Poor compliance to protocol	1	0	0
Lost to Follow-up	1	0	0
Other reason	0	4	2

Period 3: Period 2

	Sequence 1	Sequence 2	Sequence 3
STARTED	87	89	89
COMPLETED	86	86	84
NOT COMPLETED	1	3	5
Withdrawal by Subject	0	1	1
Other reason	1	1	0
Adverse Event	0	1	3
Poor compliance to protocol	0	0	1

Period 4: Period 3

	Sequence 1	Sequence 2	Sequence 3
STARTED	86	86	84
COMPLETED	84	84	84
NOT COMPLETED	2	2	0
Withdrawal by Subject	2	1	0
Adverse Event	0	1	0

Baseline Characteristics

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Reporting Groups

	Description
Sequence 1	insulin glulisine / insulin aspart / insulin lispro
Sequence 2	insulin aspart / insulin lispro / insulin glulisine
Sequence 3	insulin lispro / insulin glulisine / insulin aspart
Total	Total of all reporting groups

Baseline Measures

	Sequence 1	Sequence 2	Sequence 3	Total
Number of Participants [units: participants]	99	95	94	288
Age [units: years] Mean ± Standard Deviation	43.45 ± 13.71	45.84 ± 13.59	44.04 ± 12.87	44.43 ± 13.39
Gender [units: participants]
Female	49	54	48	151
Male	50	41	46	137
Region of Enrollment [units: participants]
United States	22	21	21	64
France	8	9	10	27
Hungary	4	4	6	14
Spain	11	9	10	30
Austria	7	9	8	24
Australia	4	4	3	11
Israel	11	11	10	32
Netherlands	8	8	7	23
United Kingdom	5	4	4	13
Italy	9	7	7	23
Sweden	9	8	7	24
Korea, Republic of	1	1	1	3
Previous insulin at study entry ^[1] [units: participants]
Insulin glulisine	4	2	2	8
Insulin aspart	32	43	42	117
Insulin lispro	63	49	50	162
Duration of treatment with previous insulin at study entry ^[2] [units: years] Mean ± Standard Deviation	4.84 ± 3.58	4.37 ± 3.05	4.79 ± 3.00	4.67 ± 3.22
Duration of treatment with insulin at study entry [units: years] Mean ± Standard Deviation	22.39 ± 13.53	23.07 ± 13.33	22.75 ± 11.08	22.73 ± 12.67
Total daily bolus insulin dose ^[3] [units: Units] Mean ± Standard Deviation	19.61 ± 9.40	18.58 ± 10.34	19.35 ± 7.78	19.18 ± 9.22
Duration of treatment with CSII (continuous subcutaneous insulin infusion) at study entry [units: years] Mean ± Standard Deviation	5.99 ± 4.83	5.52 ± 5.27	6.31 ± 4.95	5.94 ± 5.01
Total daily basal insulin infusion ^[3] [units: Units] Mean ± Standard Deviation	20.98 ± 8.84	19.99 ± 9.38	22.03 ± 9.17	21.00 ± 9.13
Body Mass Index (BMI) [units: kg/m²] Mean ± Standard Deviation	25.01 ± 3.53	25.25 ± 3.91	25.92 ± 3.98	25.39 ± 3.81
Central fasting plasma glucose ^[4] [units: mg/dL] Mean ± Standard Deviation	149.84 ± 59.03	147.45 ± 61.63	151.18 ± 64.06	149.48 ± 61.37
Glycosylated Haemoglobin (HbA1c) [units: Percent] Mean ± Standard Deviation	7.38 ± 0.69	7.36 ± 0.61	7.41 ± 0.69	7.38 ± 0.66

[1]	Total patients analyzed n=287 due to one missing data in the "sequence 2" group
[2]	Total patients analyzed n=286 due to one missing data in the "sequence 1" and in the "sequence 2" groups
[3]	Total patients analyzed n=285 due to 3 missing data: 2 in the "sequence 1" and 1 in the "sequence 2" groups
[4]	Total patients analyzed n=284 due to 4 missing data: 2 in the "sequence 1" and 2 in the "sequence 3" groups

Outcome Measures

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1. Primary:

Percentage of Patients With at Least One Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion [ Time Frame: over 13 weeks of each treatment period ]

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2. Secondary:

Monthly Rate of Unexplained Hyperglycemia and/ or Confirmed Infusion Set Occlusion [ Time Frame: over 13 weeks of each treatment period ]

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3. Secondary:

Percentage of Patients With at Least One Unexplained Hyperglycemia [ Time Frame: over 13 weeks of each treatment period ]

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4. Secondary:

Monthly Rate of Unexplained Hyperglycemia [ Time Frame: over 13 weeks of each treatment period ]

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5. Secondary:

Percentage of Patients With at Least One Confirmed Infusion Set Occlusion [ Time Frame: over 13 weeks of each treatment period ]

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6. Secondary:

Monthly Rate of Confirmed Infusion Set Occlusion [ Time Frame: over 13 weeks of each treatment period ]

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7. Secondary:

Percentage of Patients With at Least One Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis [ Time Frame: over 13 weeks of each treatment period ]

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8. Secondary:

Monthly Rate of Episode of Significant Ketosis and/ or Risk Level for Impending Diabetic Ketoacidosis [ Time Frame: over 13 weeks of each treatment period ]

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9. Secondary:

Rate of Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤ 70 mg/dL Per Patient-year [ Time Frame: over 13 weeks of each treatment period ]

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10. Secondary:

Rate of Severe Symptomatic Hypoglycemia Per Patient-year [ Time Frame: over 13 weeks of each treatment period ]

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11. Secondary:

Rate of Nocturnal Symptomatic Hypoglycemia With a Plasma Glucose (PG) ≤70 mg/dL Per Patient-year [ Time Frame: over 13 weeks of each treatment period ]

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12. Secondary:

Patients With at Least One Site Infection, Site Inflammation/Erythema, Pruritus or Isolated Pain at Injection Site [ Time Frame: over 13 weeks of each treatment period ]

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13. Secondary:

Time Interval Between Infusion Set Changes: All Changes [ Time Frame: over 13 weeks of each treatment period ]

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14. Secondary:

Time Interval Between Infusion Set Changes in Routine [ Time Frame: over 13 weeks of each treatment period ]

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15. Secondary:

Glycosylated Hemoglobin: HbA1c [ Time Frame: over 13 weeks of each treatment period ]

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16. Secondary:

Total Daily Basal Insulin Infusion [ Time Frame: over 13 weeks of each treatment period ]

Show Outcome Measure 16

17. Secondary:

Total Daily Bolus Insulin Dose [ Time Frame: over 13 weeks of each treatment period ]

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Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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
No text entered.

Results Point of Contact:

Name/Title: Medical Affairs Study Director
Organization: sanofi-aventis
e-mail: publicregistryGMA@sanofi-aventis.com

No publications provided by Sanofi

Publications automatically indexed to this study:

van Bon AC, Bode BW, Sert-Langeron C, DeVries JH, Charpentier G. Insulin glulisine compared to insulin aspart and to insulin lispro administered by continuous subcutaneous insulin infusion in patients with type 1 diabetes: a randomized controlled trial. Diabetes Technol Ther. 2011 Jun;13(6):607-14. Epub 2011 Apr 2.

Responsible Party:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00607087 History of Changes
Other Study ID Numbers:	APIDR_C_02083, 2007-003579-38
Study First Received:	January 23, 2008
Results First Received:	June 30, 2010
Last Updated:	August 26, 2010
Health Authority:	Sweden: Regional Ethical Review Board

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