Page last updated: 2024-10-30

metformin and Headache

metformin has been researched along with Headache in 7 studies

Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1.

Headache: The symptom of PAIN in the cranial region. It may be an isolated benign occurrence or manifestation of a wide variety of HEADACHE DISORDERS.

Research Excerpts

ExcerptRelevanceReference
"In this PROBE design trial, people who had recent stroke (within 3 months) with pre-diabetes were randomized to either the active arm (n = 13) receiving usual care plus Metformin XR (500 mg daily increased to a total daily dose of 1500 mg) or the control group receiving only usual care (n = 13)."9.41Feasibility trial of metformin XR in people with pre-diabetes and stroke (MIPPS)-randomised open blinded endpoint controlled trial. ( Borschmann, K; Churilov, L; Donnan, G; Ekinci, EI; Hachem, M; Lau, LH; Price, SAL; Sumithran, P; Tabesh, M; Thijs, V; Zajac, J, 2021)
"The authors hypothesized that a metformin (MET)-diet would improve symptoms of idiopathic intracranial hypertension (IIH) in women who also had polycystic ovary syndrome (PCOS) or hyperinsulinemia without PCOS."9.12Changes in weight, papilledema, headache, visual field, and life status in response to diet and metformin in women with idiopathic intracranial hypertension with and without concurrent polycystic ovary syndrome or hyperinsulinemia. ( Aregawi, D; Glueck, CJ; Goldenberg, N; Golnik, KC; Sieve, L; Wang, P, 2006)
"In this PROBE design trial, people who had recent stroke (within 3 months) with pre-diabetes were randomized to either the active arm (n = 13) receiving usual care plus Metformin XR (500 mg daily increased to a total daily dose of 1500 mg) or the control group receiving only usual care (n = 13)."5.41Feasibility trial of metformin XR in people with pre-diabetes and stroke (MIPPS)-randomised open blinded endpoint controlled trial. ( Borschmann, K; Churilov, L; Donnan, G; Ekinci, EI; Hachem, M; Lau, LH; Price, SAL; Sumithran, P; Tabesh, M; Thijs, V; Zajac, J, 2021)
"Alogliptin monotherapy maintained glycaemic control comparable to that of glipizide in elderly patients with T2DM over 1 year of treatment, with substantially lower risk of hypoglycaemia and without weight gain."5.17Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double-blind, randomized, 1-year study. ( Fleck, P; Rosenstock, J; Wilson, C, 2013)
"The authors hypothesized that a metformin (MET)-diet would improve symptoms of idiopathic intracranial hypertension (IIH) in women who also had polycystic ovary syndrome (PCOS) or hyperinsulinemia without PCOS."5.12Changes in weight, papilledema, headache, visual field, and life status in response to diet and metformin in women with idiopathic intracranial hypertension with and without concurrent polycystic ovary syndrome or hyperinsulinemia. ( Aregawi, D; Glueck, CJ; Goldenberg, N; Golnik, KC; Sieve, L; Wang, P, 2006)
" During the 52-week study period, the proportion of patients reporting ≥1 adverse event (AE) was 66."2.78Saxagliptin add-on therapy to insulin with or without metformin for type 2 diabetes mellitus: 52-week safety and efficacy. ( Barnett, AH; Charbonnel, B; Donovan, M; Fleming, D; Iqbal, N; Li, J, 2013)

Research

Studies (7)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's2 (28.57)29.6817
2010's4 (57.14)24.3611
2020's1 (14.29)2.80

Authors

AuthorsStudies
Tabesh, M1
Hachem, M1
Lau, LH1
Borschmann, K1
Churilov, L1
Price, SAL1
Sumithran, P1
Donnan, G1
Zajac, J1
Thijs, V1
Ekinci, EI1
Krüger, HJ1
De Wet, R1
Blumberg, LH1
Weyer, J1
Lemke, FG1
Rosenstock, J1
Wilson, C1
Fleck, P1
Barnett, AH1
Charbonnel, B1
Li, J1
Donovan, M1
Fleming, D1
Iqbal, N1
Matyjaszek-Matuszek, B1
Lenart-Lipińska, M1
Rogalska, D1
Nowakowski, A1
Glueck, CJ1
Golnik, KC1
Aregawi, D1
Goldenberg, N1
Sieve, L1
Wang, P1
Nagai, T1
Tomizawa, T1
Tonooka, N1
Mita, Y1
Misumi, S1
Mori, M1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Ins[NCT00757588]Phase 3455 participants (Actual)Interventional2008-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Adjusted Mean Change From Baseline in A1C Levels (Last Observation Carried Forward [LOCF])

Change from baseline: post-pre. Adjusted for baseline (value and metformin use). ANCOVA model: difference between week t and baseline values=baseline values + treatment + metformin use (NCT00757588)
Timeframe: Baseline to Week 24

InterventionPercentage of change (Mean)
Saxagliptin, 5 mg + Insulin-0.73
Placebo + Insulin-0.32

Change From Baseline in 120-minute PPG Values During an MTT

An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal. (NCT00757588)
Timeframe: Baseline to Week 24

Interventionmg/dL (Mean)
Saxagliptin, 5 mg + Insulin-27.2
Placebo + Insulin-4.2

Change From Baseline in Fasting Plasma Glucose Values

(NCT00757588)
Timeframe: Baseline to Week 24

Interventionmg/dL (Mean)
Saxagliptin, 5 mg + Insulin-10.1
Placebo + Insulin-6.1

Change From Baseline in Mean Total Daily Dose of Insulin (MTDDI) (LOCF)

Based on information recorded in the participant's daily diary. The MTDDI was calculated at every visit using the values patients recorded since the last regularly scheduled visit (minimum of 80% of days with a value). At every visit, the MTDDI was compared with the participant's baseline MTDDI (measured during a 4-week lead-in period) to identify any changes in insulin use at that visit compared with insulin use at baseline. (NCT00757588)
Timeframe: Baseline to Week 24

InterventionUnits (Mean)
Saxagliptin, 5 mg + Insulin1.71
Placebo + Insulin5.01

Change From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Meal Tolerance Test (MTT)

An MTT is a 2-part test that measures glucose and insulin levels after an overnight fast and before ingesting a meal consisting of a nutritional drink and power bar and again at prespecified times (30, 60, 120, and 180 minutes) after the start of ingestion of the meal (NCT00757588)
Timeframe: Baseline to Week 24

Interventionmg*min/dL (Mean)
Saxagliptin, 5 mg + Insulin-4548.5
Placebo + Insulin-718.8

Number of Participants With Abnormal Changes From Baseline in Electrocardiogram (ECG) Results

"ECG abnormalities included those in nonspecific other categories (Other nonspecific ST/T, Other intraventricular conduction defect, Other, and Other rhythm abnormalities)and nonspecific findings, such as sinus bradycardia, sinus arrythmia, sinus tachycardia, poor R-wave progression, and ventricular premature contractions." (NCT00757588)
Timeframe: Baseline to Week 52

InterventionParticipants (Number)
Saxagliptin, 5 mg + Insulin15
Placebo + Insulin11

Percentage of Participants Achieving a Therapeutic Glycemic Response

Therapeutic glycemic response is defined as an A1C<7%. Significance was not interpreted with a p value. (NCT00757588)
Timeframe: Baseline to Week 24

InterventionPercentage of participants (Number)
Saxagliptin, 5 mg + Insulin17.3
Placebo + Insulin6.7

Mean Changes From Baseline in Heart Rate

(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52

,
InterventionBeats per minute (Number)
Week 2 (n=294, 147)Week 4 (n=293, 144)Week 6 (n=280, 141)Week 8 (n=290, 142)Week 12 (n=286, 144)Week 16 (n=278, 139)Week 20 (n=276, 137)Week 24 (n=273, 134)Week 28 (n=264, 132)Week 36 (n=261, 129)Week 44 (n=250, 125)Week 52 (n=246, 125)
Placebo + Insulin-0.7-1.0-0.9-0.70.2-0.60.4-1.0-0.6-0.0-0.70.2
Saxagliptin, 5 mg + Insulin-0.5-0.5-0.5-0.00.3-1.0-0.50.0-1.00.00.2-0.3

Mean Changes From Baseline in Systolic and Diastolic Blood Pressure Readings

(NCT00757588)
Timeframe: Baseline to Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 36, 44, and 52

,
Interventionmm Hg (Number)
Systolic blood pressure (Week 2) (n=294, 147)Systolic blood pressure (Week 4) (n=293, 144)Systolic blood pressure (Week 6) (n=280, 141)Systolic blood pressure (Week 8) (n=290, 142)Systolic blood pressure (Week 12) (n=286, 144)Systolic blood pressure (Week 16) (n=278, 139)Systolic blood pressure (Week 20) (n=276, 137)Systolic blood pressure (Week 24) (n=273, 134)Systolic blood pressure (Week 28) (n=264, 132)Systolic blood pressure (Week 36) (n=261, 129)Systolic blood pressure (Week 44) (n=250, 125)Systolic blood pressure (Week 52) (n=246, 125)Diastolic blood pressure (Week 2) (n=294, 147)Diastolic blood pressure (Week 4) (n=293, 144)Diastolic blood pressure (Week 6) (n=280, 141)Diastolic blood pressure (Week 8) (n=290, 142)Diastolic blood pressure (Week 12) (n=286, 144)Diastolic blood pressure (Week 16) (n=278, 139)Diastolic blood pressure (Week 20) (n=276, 137)Diastolic blood pressure (Week 24) (n=273, 134)Diastolic blood pressure (Week 28) (n=264, 132)Diastolic blood pressure (Week 36) (n=261, 129)Diastolic blood pressure (Week 44) (n=250, 125)Diastolic blood pressure (Week 52) (n=246, 125)
Placebo + Insulin2.30.01.02.42.21.11.3-0.11.83.62.61.01.41.80.32.11.01.31.10.50.20.20.40.1
Saxagliptin, 5 mg + Insulin-1.0-1.2-0.8-0.8-1.7-1.2-0.6-1.5-1.4-0.7-0.60.00.10.00.0-0.5-0.8-1.1-0.7-1.7-1.6-1.2-0.3-0.5

Number of Participants With at Least 1 Adverse Event (AE), at Least 1 Treatment-related AE, Death as Outcome, at Least 1 Serious Adverse Event (SAE), at Least 1 Treatment-related SAE, Discontinuations Due to SAEs, and Discontinuations Due to AEs

An AE is any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; requires inpatient hospitalization; or prolongs existing hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment. (NCT00757588)
Timeframe: Baseline to Week 52, continuously

,
InterventionParticipants (Number)
At least 1 AEAt least 1 treatment-related AEDeathsAt least 1 SAEAt least 1 treatment-related SAEDiscontinuations due to SAEsDiscontinuations due to AEs
Placebo + Insulin10834013003
Saxagliptin, 5 mg + Insulin20256225349

Number of Participants With Marked Laboratory Abnormalities During the 24-Week ST + 52-Week LT Treatment Period

"Marked abnormality=a laboratory value lying outside the predefined criteria and more extreme (farther from the limit)on-treatment than at baseline. ULN=upper limit of normal; LLN=lower limit of normal; prx=pre-RX=pretreatment.~Criteria 1: if prx=0 use >=2, if prx=0.5 or 1 use >=3, if prx=2 use 4." (NCT00757588)
Timeframe: Baseline and during and up to 14 days after last dose of study drug (in Week 52)

,
InterventionParticipants (Number)
Hemoglobin <8 g/dL (n=300; 150)Hematocrit <0.75*prx (n=300; 150)Platelets <50*10^9 c/L (n=297; 145)Platelets >1.5*ULN (n=297; 145)Leukocytes <2*1000 c/uL (n=300; 150)Neutrophils <1*1000 c/uL (n=296; 150)Eosinophils >0.9*1000 c/uL (n=296; 150)Lymphocytes <=0.75*1000 c/uL (n=296; 150)Alkaline phosphatase >3*prx & >ULN (n=302; 150)Alkaline phosphatase >1.5 ULN (n=302; 150)Aspartate aminotransferase >3* ULN (n=298; 148)Aspartate aminotransferase>5* ULN (n=298; 148)Aspartate aminotransferase >10*ULN (n=298; 148)Aspartate aminotransferase >20*ULN (n=298; 148)Alanine transaminase >3*ULN (n=300; 148)Alanine transaminase >5*ULN (n=300; 148)Alanine transaminase >10*ULN (n=300; 148)Alanine transaminase >20*ULN (n=300; 148)Bilirubin, total >2 mg/dL (n=301; 150)Bilirubin, total >1.5*ULN (n=301; 150)Bilirubin, total >2*ULN (n=301; 150)Blood urea nitrogen >2*prx & >ULN (n=302; 150)Creatinine >2.5 mg/dL (n=303; 150)Glucose, serum fasting <50 mg/dL (n=0; 0)Glucose, serum fasting >500 mg/dL (n=0; 0)Glucose, serum unspecified <50 mg/dL (n=0; 0)Glucose, serum unspecified >500 mg/dL (n=0; 0)Glucose, plasma fasting <50 mg/dL (n=301;150)Glucose, plasma fasting >500 mg/dL (n=301;150)Glucose, plasma unspecified <50 mg/dL (n=272; 133)Glucose, plasma unspecified >500 mg/d (n=272; 133)Sodium, serum <0.9*prx & <=130 mEq/L (n=302; 150)Sodium, serum >1.1*prx & >=150 mEq/L (n=302; 150)Potassium, serum <0.8 prx &<=3.2 mEq/L(n=300; 148)Potassium, serum >1.2*prx&>= 6.0 mEq/L(n=300; 148)Chloride, serum <90 mEq/L (n=302; 150)Chloride, serum >120 mEq/L (n=302; 150)Albumin <0.9*LLN; if prxCreatine kinase >5*ULN (n=301, 148)Uric acid >1.5*ULN; if prx >ULN, >2 (n=0,0)Protein urine (see criteria 1) (n=297,146)Blood urine (see criteria 1) (n=297; 146)Red blood cells urine (see criteria 1) (n=53; 31)White blood cells urine (see criteria 1)(n=115;53)
Placebo + Insulin020010721500003000010700000011100180002032310
Saxagliptin, 5 mg + Insulin22000193210210051000005000005051103810160814835

Percentage of Participants With Reported and Confirmed Hypoglycemia

Confirmed hypoglycemia=fingerstick glucose measurement of ≤50 mg/dL with associated symptoms/ (NCT00757588)
Timeframe: Baseline to Week 52

,
InterventionPercentage of Participants (Number)
ReportedConfirmed
Placebo + Insulin24.56.6
Saxagliptin, 5 mg + Insulin19.47.6

Shift in Absolute Lymphocyte Counts From Baseline to Selected Visits (LOCF)

Absolute lymphocyte count=value*10^3 c/uL (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52

,
InterventionParticipants (Number)
Baseline <= 0.75; Week 24 <= 0.75Baseline <= 0.75; Week 24 >0.75- <= 5.00Baseline <= 0.75; Week 24 >5.00Baseline >0.75- <= 5.00; Week 24 <= 0.75Baseline >0.75- <= 5.00; Week 24 >0.75- <= 5.00Baseline >0.75- <= 5.00; Week 24 >5.00Baseline >5.00; Week 24 <= 0.75Baseline >5.00; Week 24 >0.75- <= 5.00Baseline >5.00; Week 24 >5.00Baseline <= 0.75; Week 52 <= 0.75Baseline <= 0.75; Week 52 >0.75- <= 5.00Baseline <= 0.75; Week 52 >5.00Baseline >0.75- <= 5.00; Week 52 <= 0.75Baseline >0.75- <= 5.00; Week 52 >0.75- <= 5.00Baseline >0.75- <= 5.00; Week 52 >5.00Baseline >5.00; Week 52 <= 0.75Baseline >5.00; Week 52 >0.75- <= 5.00Baseline >5.00; Week 52 >5.00
Placebo + Insulin0200148000002001471000
Saxagliptin, 5 mg + Insulin0001293100100002950001

Shift in Platelet Counts From Baseline to Selected Visits (LOCF)

Platelet count=value*10^9 c/L (NCT00757588)
Timeframe: Baseline and Weeks 24 and 52

,
InterventionParticipants (Number)
Baseline <= 100; Week 24 <= 100Baseline <= 100; Week 24 >100 - <= 600Baseline <= 100; Week 24 >600Baseline >100 - <= 600; Week 24 <= 100Baseline >100 - <= 600; Week 24 >100 - <= 600Baseline >100 - <= 600; Week 24 >600Baseline >600; Week 24 <= 100Baseline >600; Week 24 >100 - <= 600Baseline >600; Week 24 >600Baseline <= 100; Week 52 <= 100Baseline <= 100; Week 52 >100 - <= 600Baseline <= 100; Week 52 >600Baseline >100 - <= 600; Week 52 <= 100Baseline >100 - <= 600; Week 52 >100 - <= 600Baseline >100 - <= 600; Week 52 >600Baseline >600; Week 52 <= 100Baseline >600; Week 52 >100 - <= 600Baseline >600; Week 52 >600
Placebo + Insulin0001143000001001440000
Saxagliptin, 5 mg + Insulin0001296000000022950000

Trials

5 trials available for metformin and Headache

ArticleYear
Feasibility trial of metformin XR in people with pre-diabetes and stroke (MIPPS)-randomised open blinded endpoint controlled trial.
    Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia, 2021, Volume: 86

    Topics: Adult; Aged; Australia; Delayed-Action Preparations; Feasibility Studies; Female; Headache; Humans;

2021
Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double-blind, randomized, 1-year study.
    Diabetes, obesity & metabolism, 2013, Volume: 15, Issue:10

    Topics: Aged; Aged, 80 and over; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-Peptidase IV Inhibitor

2013
Saxagliptin add-on therapy to insulin with or without metformin for type 2 diabetes mellitus: 52-week safety and efficacy.
    Clinical drug investigation, 2013, Volume: 33, Issue:10

    Topics: Adamantane; Adolescent; Adult; Aged; Diabetes Mellitus, Type 2; Dipeptides; Dipeptidyl-Peptidase IV

2013
Exenatide twice daily versus insulin glargine for the treatment of type 2 diabetes in Poland - subgroup data from a randomised multinational trial GWAA.
    Endokrynologia Polska, 2013, Volume: 64, Issue:5

    Topics: Administration, Oral; Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Administration Sch

2013
Changes in weight, papilledema, headache, visual field, and life status in response to diet and metformin in women with idiopathic intracranial hypertension with and without concurrent polycystic ovary syndrome or hyperinsulinemia.
    Translational research : the journal of laboratory and clinical medicine, 2006, Volume: 148, Issue:5

    Topics: Adolescent; Adult; Body Mass Index; Body Weight; Combined Modality Therapy; Diet, Reducing; Female;

2006

Other Studies

2 other studies available for metformin and Headache

ArticleYear
Atypical presentation of Crimean-Congo haemorrhagic fever: Lessons learned.
    South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde, 2019, Jan-31, Volume: 109, Issue:2

    Topics: Acidosis; Comorbidity; Diabetes Mellitus, Type 2; Diabetic Ketoacidosis; Diagnosis, Differential; Dr

2019
Diabetes mellitus with left transverse sinus thrombosis and right transverse sinus aplasia.
    Diabetes research and clinical practice, 2001, Volume: 51, Issue:1

    Topics: Aged; Aspirin; Cerebral Angiography; Cranial Sinuses; Diabetes Mellitus, Type 2; Diabetic Angiopathi

2001