INNOVATION Study - Telmisartan (Micardis) in Incipient Diabetic Nephropathy

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00153088
First received: September 9, 2005
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

The aim of this study is to compare the preventive effect of Telmisartan(Micardis) versus placebo control on the transition to overt nephropathy in patients with diabetic nephropathy manifesting microalbuminuria associated with type II diabetes, and to evaluate the efficacy and safety of Telmisart (Micardis, Gliosartan, Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan) for diabetic nephropathy patients.


Condition Intervention Phase
Diabetic Nephropathies
Drug: Telmisartan capsule 40 mg
Drug: Placebo
Drug: Telmisartan capsule 80 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Preventive Effect of BIBR277 (Telmisartan) in Diabetic Nephropathy on Transition From Incipient to Overt Nephropathy - Incipient to Overt : Angiotensin 2 Receptor Blocker, Telmisartan, Investigation on Type 2 Diabetic Nephropathy (INNOVATION Study -

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Non-transition to overt nephropathy

Secondary Outcome Measures:
  • Change in renal parameters Composite endpoint

Enrollment: 527
Study Start Date: January 2003
Estimated Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Detailed Description:

A prospective, randomised, double-blind, multicentric and comparative study to investigate, on a long-term basis, the preventive effect on the transition to overt nephropathy and the safety of Telmisartan (Micardis) against placebo in patients with diabetic nephropathy, manifesting microalbuminuria associated with type II diabetes.

Study Hypothesis:

The hypothesis is that Telmisartan (Micardis) at 40 mg or 80 mg versus placebo control in patients with concurrent type II diabetic mellitus or diabetic nephropathy demonstrating microalbuminuria, has the preventive effect on transition from incipient to overt nephropathy.

Comparison(s):

The primary endpoint is defined as the transition from incipient to overt nephropathy, and the non-transition curve will be demonstrated based on the Kaplan-Meier method. The evaluation criteria for the point to transition to overt nephropathy is defined as urinary albumin to creatinine ratios at consecutive 2 measuring points increasing over 300 mg/g-Creatinine and excess 30% increase comparing with the baseline value. The curve of non-transition will be compared with Logrank test. Those in BIBR277 groups are sequentially compared with that in the placebo group by the closed testing procedure.

  Eligibility

Ages Eligible for Study:   30 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatients who are able to visit the study site throughout the run-in period
  2. Aged 30 and 74 years
  3. Type II diabetes mellitus
  4. Patients with urinary albumin to creatinine ratios within the following ranges at 2 measuring points during the run-in period 1) the first-morning voided urine, iin the range of 100 to 300 mg/g Creatinine 2) < 100 mg/g Creatinine at either point of Visit 2 or 3, but in the range of 100 to 300 mg/g Creatinine at follow-up
  5. Serum creatinine level of < 1.5 mg/dL in male and < 1.3 mg/dL in female
  6. Normotensive or hypertensive patients
  7. Patients taking AT1 antagonists or ACE inhibitors at screening, but are able to stop those drugs during the study
  8. Patients who are able to provide written informed consent in accordance with the Good Clinical Practice (GCP) and other relevant laws such as the Pharmaceutical Affairs Law

Exclusion Criteria:

  1. Age of onset of type 2 diabetes is < 30 years
  2. Type I diabetes
  3. Urinary albumin to creatinine ratio of > 300 mg/g Creatinine
  4. HbA1c 9%
  5. Seated SBP 180 mmHg or DBP 110 mmHg
  6. Findings suggesting a renal disease other than diabetic nephropathy; such as post renal transplantation, history of non-diabetic renal disease, marked haematuria, complication of urinary tract infection
  7. Cardiovascular diseases:

    • Patients with unstable angina, myocardial infarction, CABG, PTCA within 6 months before
    • CHF with NYHA III-IV
    • TIA within 6 months
    • Stroke within 6 months
    • AV block (grade II-III) or AF
    • Serious arrhythmia
    • Known or suspected secondary HT
  8. History of angioedema during administration of ARB/ACE-i
  9. Hypersensitivity
  10. History of sudden exacerbation of renal function due to ARB/ACE-i
  11. Markedly poor bile secretion
  12. Hepatic dysfunction: SGPT (ALT) or SGOT (AST) 100 IU/L
  13. Serum potassium level < 3.5 mEq/L or 5.1 mEq/L
  14. Unable to discontinue ARB/ACE-i
  15. Require prolonged administration of any medications affecting blood pressure, except diuretics, or blockers, and CCB
  16. Untreated sodium depletion
  17. Pre-menopausal females who meet any one of the following:

    • Pregnant or possibly pregnant
    • Breast-feeding
    • Hope to be pregnant during the study period
    • Even when a patient is confirmed not to meet the above criteria at the start of the study, a female patient who has the potential to be pregnant during the study is to undergo pregnancy tests. If the result turns positive, the study medication should be discontinued.
  18. Malignant tumour or other diseases requiring oral or injection immunosuppressants
  19. Non-compliance
  20. History of drug or alcohol abuse
  21. Participated in other clinical studies within 3 months
  22. Any other conditions investigators judged as ineligible
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00153088

  Hide Study Locations
Locations
Japan
Boehringer Ingelheim Investigational Site
Adachi-ku, Tokyo, Japan, 121-0813
Boehringer Ingelheim Investigational Site
Amagasaki, Hyogo, Japan, 661-0002
Boehringer Ingelheim Investigational Site
Arakawa-ku, Tokyo, Japan, 116-0011
Boehringer Ingelheim Investigational Site
Asaguchi-gun, Okayama, Japan, 719-0113
Boehringer Ingelheim Investigational Site
Asahi, Chiba, Japan, 289-2511
Boehringer Ingelheim Investigational Site
Asahikawa, Hokkaido, Japan, 070-8610
Boehringer Ingelheim Investigational Site
Asahikwa, Hokkaido, Japan, 070-8530
Boehringer Ingelheim Investigational Site
Atami, Shizuoka, Japan, 413-0012
Boehringer Ingelheim Investigational Site
Atsugi,Kanagawa, Japan, 243-0013
Boehringer Ingelheim Investigational Site
Chikugo, Fukuoka, Japan, 833-0041
Boehringer Ingelheim Investigational Site
Chisagata-gun, Nagano, Japan, 386-0493
Boehringer Ingelheim Investigational Site
Chisagata-gun, Nagano, Japan, 386-0396
Boehringer Ingelheim Investigational Site
Chitose, Hokkaido, Japan, 066-0081
Boehringer Ingelheim Investigational Site
Chiyoda, Tokyo, Japan, 100-0005
Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan, 101-8326
Boehringer Ingelheim Investigational Site
Chiyoda-ku, Tokyo, Japan, 102-8798
Boehringer Ingelheim Investigational Site
Ebina, Kanagawa, Japan, 243-0432
Boehringer Ingelheim Investigational Site
Fujisawa, Kanagawa, Japan, 252-0802
Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka, Japan, 812-0053
Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka, Japan, 814-0163
Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka, Japan, 814-0171
Boehringer Ingelheim Investigational Site
Fukuyama, Hiroshima, Japan, 720-0825
Boehringer Ingelheim Investigational Site
Funabashi, Chiba, Japan, 247-0805
Boehringer Ingelheim Investigational Site
Furukawa, Miyagi, Japan, 989-6183
Boehringer Ingelheim Investigational Site
Gifu, Gifu, Japan, 501-1198
Boehringer Ingelheim Investigational Site
Gobo, Wakayama, Japan, 644-0011
Boehringer Ingelheim Investigational Site
Hachioji, Tokyo, Japan, 193-0998
Boehringer Ingelheim Investigational Site
Hakodate, Hokkaido, Japan, 040-8585
Boehringer Ingelheim Investigational Site
Hanamaki, Iwate, Japan, 025-0075
Boehringer Ingelheim Investigational Site
Hannan, Osaka, Japan, 599-0202
Boehringer Ingelheim Investigational Site
Hashima-gun, Gifu, Japan, 501-6062
Boehringer Ingelheim Investigational Site
Hatsukaichi, Hiroshima, Japan, 738-0033
Boehringer Ingelheim Investigational Site
Hirakata, Osaka, Japan, 573-1196
Boehringer Ingelheim Investigational Site
Hitachiota, Ibaragi, Japan, 313-0014
Boehringer Ingelheim Investigational Site
Ichinomiya, Aichi, Japan, 491-8551
Boehringer Ingelheim Investigational Site
Iida, Nagano, Japan, 395-8558
Boehringer Ingelheim Investigational Site
Ikeda, Osaka, Japan, 563-8510
Boehringer Ingelheim Investigational Site
Inashiki-gun, Ibaragi, Japan, 300-0395
Boehringer Ingelheim Investigational Site
Isehara, Kanagawa, Japan, 259-1193
Boehringer Ingelheim Investigational Site
Isezaki, Gunma, Japan, 372-0001
Boehringer Ingelheim Investigational Site
Itami, Hyogo, Japan, 664-8533
Boehringer Ingelheim Investigational Site
Izumisano, Osaka, Japan, 598-0048
Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa, Japan, 247-0056
Boehringer Ingelheim Investigational Site
Kamakura, Kanagawa, Japan, 247-0055
Boehringer Ingelheim Investigational Site
Kamogawa, Chiba, Japan, 296-8602
Boehringer Ingelheim Investigational Site
Katsushika-ku, Tokyo, Japan, 125-0041
Boehringer Ingelheim Investigational Site
Kawagoe, Saitama, Japan, 350-0042
Boehringer Ingelheim Investigational Site
Kawaguchi, Saitama, Japan, 332-8558
Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa, Japan, 216-8511
Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa, Japan, 211-0035
Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa, Japan, 210-0013
Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa, Japan, 210-0924
Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa, Japan, 215-0022
Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa, Japan, 211-8510
Boehringer Ingelheim Investigational Site
Kisarazu, Chiba, Japan, 292-8535
Boehringer Ingelheim Investigational Site
Kita-katushika-gun, Saitama, Japan, 349-1105
Boehringer Ingelheim Investigational Site
Kita-ku, Tokyo, Japan, 114-0004
Boehringer Ingelheim Investigational Site
Kitami, Hokkaido, Japan, 090-0040
Boehringer Ingelheim Investigational Site
Kobe, Hyogo, Japan, 654-0047
Boehringer Ingelheim Investigational Site
Kobe, Hyogo, Japan, 651-1242
Boehringer Ingelheim Investigational Site
Kochi, Kochi, Japan, 781-0011
Boehringer Ingelheim Investigational Site
Kochi, Kochi, Japan, 780-8562
Boehringer Ingelheim Investigational Site
Kodaira, Tokyo, Japan, 187-0003
Boehringer Ingelheim Investigational Site
Kodaira, Tokyo, Japan, 187-8510
Boehringer Ingelheim Investigational Site
Komaki, Aichi, Japan, 485-8520
Boehringer Ingelheim Investigational Site
Komatsushima, Tokushima, Japan, 773-8502
Boehringer Ingelheim Investigational Site
Koriyama, Fukushima, Japan, 963-8585
Boehringer Ingelheim Investigational Site
Koriyama, Fukushima, Japan, 963-8563
Boehringer Ingelheim Investigational Site
Koriyama,Fukushima, Japan, 963-8022
Boehringer Ingelheim Investigational Site
Kounan, Aichi, Japan, 483-8702
Boehringer Ingelheim Investigational Site
Kumagaya, Saitama, Japan, 360-0854
Boehringer Ingelheim Investigational Site
Kurashiki, Okayama, Japan, 701-0192
Boehringer Ingelheim Investigational Site
Kurashiki, Okayama, Japan, 710-0826
Boehringer Ingelheim Investigational Site
Kyoto, Kyoto, Japan, 615-8087
Boehringer Ingelheim Investigational Site
Matsuyama, Ehime, Japan, 790-0024
Boehringer Ingelheim Investigational Site
Matsuyama, Ehime, Japan, 791-8026
Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo, Japan, 106-0045
Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo, Japan, 108-0073
Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo, Japan, 192-0363
Boehringer Ingelheim Investigational Site
Musashino, Tokyo, Japan, 180-8610
Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan, 462-0802
Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan, 454-0933
Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan, 462-0825
Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan, 465-0025
Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan, 451-8511
Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan, 455-8530
Boehringer Ingelheim Investigational Site
Nagoya, Aichi, Japan, 467-8602
Boehringer Ingelheim Investigational Site
Nakano-ku, Tokyo, Japan, 164-0011
Boehringer Ingelheim Investigational Site
Nangoku, Kochi, Japan, 783-8505
Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo, Japan, 663-8501
Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo, Japan, 662-0971
Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo, Japan, 663-8211
Boehringer Ingelheim Investigational Site
Noda, Chiba, Japan, 278-8501
Boehringer Ingelheim Investigational Site
Nomi, Ishikawa, Japan, 923-1226
Boehringer Ingelheim Investigational Site
Obihiro, Hokkaido, Japan, 080-0848
Boehringer Ingelheim Investigational Site
Odawara, Kanagawa, Japan, 250-0011
Boehringer Ingelheim Investigational Site
Oita, Oita, Japan, 870-0039
Boehringer Ingelheim Investigational Site
Okawa, Fukuoka, Japan, 831-0016
Boehringer Ingelheim Investigational Site
Okayama, Okayama, Japan, 701-1192
Boehringer Ingelheim Investigational Site
Okayama, Okayama, Japan, 700-8505
Boehringer Ingelheim Investigational Site
Okayama, Okayama, Japan, 700-8558
Boehringer Ingelheim Investigational Site
Osaka, Japan, 545-0021
Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan, 553-0003
Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan, 543-0035
Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan, 543-0002
Boehringer Ingelheim Investigational Site
Osaka-sayama, Osaka, Japan, 589-8511
Boehringer Ingelheim Investigational Site
Otaru, Hokkaido, Japan, 047-8550
Boehringer Ingelheim Investigational Site
Oyama, Tochigi, Japan, 323-0022
Boehringer Ingelheim Investigational Site
Sagamihara, Kanagawa, Japan, 228-8555
Boehringer Ingelheim Investigational Site
Sagamihara, Kanagawa, Japan, 229-1125
Boehringer Ingelheim Investigational Site
Sakai, Osaka, Japan, 590-0132
Boehringer Ingelheim Investigational Site
Sakai, Osaka, Japan, 591-8025
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 060-0033
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 003-0023
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 006-0811
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 064-8622
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 003-8585
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 062-0007
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 001-0024
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 004-0053
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 001-0023
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 060-0062
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 062-0931
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 064-0953
Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido, Japan, 065-0027
Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan, 981-8501
Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan, 980-0021
Boehringer Ingelheim Investigational Site
Setagaya-ku, Tokyo, Japan, 158-8531
Boehringer Ingelheim Investigational Site
Seto, Aichi, Japan, 489-8642
Boehringer Ingelheim Investigational Site
Shibetsu, Hokkaido, Japan, 095-0014
Boehringer Ingelheim Investigational Site
Shibuya-ku, Tokyo, Japan, 150-8935
Boehringer Ingelheim Investigational Site
Shibuya-ku, Tokyo, Japan, 150-0013
Boehringer Ingelheim Investigational Site
Shinagawa, Tokyo, Japan, 140-8522
Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan, 160-0023
Boehringer Ingelheim Investigational Site
Shinjyuku-ku, Tokyo, Japan, 162-8666
Boehringer Ingelheim Investigational Site
Shiojiri, Nagano, Japan, 399-0702
Boehringer Ingelheim Investigational Site
Sunagawa, Hokkaido, Japan, 073-0196
Boehringer Ingelheim Investigational Site
Takamatsu, Kagawa, Japan, 760-0018
Boehringer Ingelheim Investigational Site
Takarazuka, Hyogo, Japan, 665-0827
Boehringer Ingelheim Investigational Site
Takasaki, Gunma, Japan, 370-0069
Boehringer Ingelheim Investigational Site
Takatsuki, Osaka, Japan, 569-1096
Boehringer Ingelheim Investigational Site
Tama, Tokyo, Japan, 206-0025
Boehringer Ingelheim Investigational Site
Toride, Ibaraki, Japan, 302-0022
Boehringer Ingelheim Investigational Site
Tosu, Saga, Japan, 841-0061
Boehringer Ingelheim Investigational Site
Toyohashi, Aichi, Japan, 441-8021
Boehringer Ingelheim Investigational Site
Toyohashi, Aichi, Japan, 441-8570
Boehringer Ingelheim Investigational Site
Toyota, Aichi, Japan, 471-8513
Boehringer Ingelheim Investigational Site
Tsuchiura, Ibaraki, Japan, 300-0047
Boehringer Ingelheim Investigational Site
Tsuchiura,Ibaraki, Japan, 300-0053
Boehringer Ingelheim Investigational Site
Tsukuba, Ibaragi, Japan, 305-0812
Boehringer Ingelheim Investigational Site
Uji, Kyoto, Japan, 611-0013
Boehringer Ingelheim Investigational Site
Ushiku, Ibaraki, Japan, 300-1296
Boehringer Ingelheim Investigational Site
Uwajima, Ehime, Japan, 798-8510
Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan, 240-8585
Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan, 227-0046
Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan, 236-0016
Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan, 227-0062
Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan, 247-0006
Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan, 222-0033
Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan, 235-0045
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Nippon Boehringer Ingelheim Co., Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00153088     History of Changes
Other Study ID Numbers: 502.413
Study First Received: September 9, 2005
Last Updated: October 31, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Urologic Diseases
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014